ESTHER-2: Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01956123
Collaborator
(none)
513
13
4
33.3
39.5
1.2
Study Details
Study Description
Brief Summary
This trial investigates the immunogenicity of FE 999049 in repeated cycles.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
513 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme
Actual Study Start Date
:
Mar 26, 2014
Actual Primary Completion Date
:
May 1, 2015
Actual Study Completion Date
:
Jan 3, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A Follitropin Delta (FE 999049) (COS cycle 2) |
Drug: Follitropin Delta (FE 999049)
|
| Active Comparator: B Follitropin Alfa (GONAL-F) (COS cycle 2) |
Drug: Follitropin Alfa (GONAL-F)
|
| Experimental: C Follitropin Delta (FE 999049) (COS cycle 3) |
Drug: Follitropin Delta (FE 999049)
|
| Active Comparator: D Follitropin Alfa (GONAL-F) (COS cycle 3) |
Drug: Follitropin Alfa (GONAL-F)
|
Outcome Measures
Primary Outcome Measures
- Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles [Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose]
The proportion (percentage) of subjects with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.
Secondary Outcome Measures
- Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles [Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose]
The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.
- Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles [Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose]
The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented.
- Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle [≤9 days after triggering of final follicular maturation.]
The proportion (percentage) of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.
- Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle [End-of-stimulation (up to 20 stimulation days)]
Proportion (percentage) of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented.
- Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle [5-6 weeks after blastocyst transfer]
Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.
- Implantation Rate for Each Controlled Ovarian Stimulation Cycle [5-6 weeks after blastocyst transfer]
Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.
- Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle [10-11 weeks after blastocyst transfer]
Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.
- Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle [10-11 weeks after blastocyst transfer]
Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.
- Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle [End-of-stimulation (up to 20 stimulation days)]
Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented.
- Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle [>9 days after triggering of final follicular maturation]
Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation.
- Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle [End-of-stimulation (up to 20 stimulation days)]
Incidences of confirmed technical malfunction of administration pen are presented.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Informed Consent Documents signed prior to screening evaluations related to this protocol
-
Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
-
Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
-
Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
-
Failure to achieve ongoing pregnancy in the previous cycle(s).
Exclusion Criteria:
-
Non-compliance to protocol compliance in the previous cycle(s).
-
Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
-
One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
-
Severe OHSS in a previous cycle.
-
Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
-
Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Brussel (there may be other sites in this country) | Brussels | Belgium | ||
| 2 | Fertilitat and PUC-RS (there may be other sites in this country) | Porto Alegre | Brazil | ||
| 3 | Pacific Centre for Reproductive Medicine | Burnaby | British Columbia | Canada | |
| 4 | Olive Fertility Centre | Vancouver | British Columbia | Canada | |
| 5 | Ottawa Fertility Centre | Ottawa | Ontario | Canada | |
| 6 | IVF CUBE SE (there may be other sites in this country) | Prague | Czechia | ||
| 7 | Rigshospitalet Fertilitetsklinikken (there may be other sites in this country) | Copenhagen | Denmark | ||
| 8 | Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country) | Lille | France | ||
| 9 | Centro Natalità San Raffaele (there may be other sites in this country) | Milano | Italy | ||
| 10 | The nOvum Clinic (there may be other sites in this country) | Warszawa | Poland | ||
| 11 | IVF & Reproductive Genetics Center (there may be other sites in this country) | Moscow | Russian Federation | ||
| 12 | IVI Sevilla (there may be other sites in this country) | Sevilla | Spain | ||
| 13 | Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country) | Glasgow | United Kingdom |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01956123
Other Study ID Numbers:
- 000071
- 2013-001616-30
- U1111-1147-6922
First Posted:
Oct 8, 2013
Last Update Posted:
Jul 15, 2021
Last Verified:
Aug 1, 2018
Study Results
Participant Flow
| Recruitment Details | A total of 32 investigational sites included subjects to the trial : 3 in Belgium, 3 in Brazil, 3 in Canada, 3 in the Czech Republic, 2 in Denmark, 2 in Italy, 2 in Poland, 2 in Russia, 10 in Spain and 2 in United Kingdom. |
|---|---|
| Pre-assignment Detail | Subjects who participated in Trial 000004 (NCT01956110) (controlled ovarian stimulation [COS] cycle 1) & failed to achieve ongoing pregnancy were eligible for the trial. For COS cycle 2, 520 subjects were screened and 513 enrolled. For COS cycle 3, 190 subjects were screened and 189 enrolled. Subjects were exposed to the same IMP as in COS cycle 1. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 international units (IU) based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Period Title: COS Cycle 2 | ||||
| STARTED | 252 | 261 | 0 | 0 |
| COMPLETED | 238 | 254 | 0 | 0 |
| NOT COMPLETED | 14 | 7 | 0 | 0 |
| Period Title: COS Cycle 2 | ||||
| STARTED | 0 | 0 | 95 | 93 |
| COMPLETED | 0 | 0 | 89 | 91 |
| NOT COMPLETED | 0 | 0 | 6 | 2 |
Baseline Characteristics
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | Total |
|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | Total of all reporting groups |
| Overall Participants | 252 | 261 | 513 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
252
100%
|
261
100%
|
513
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
95
37.7%
|
93
35.6%
|
188
36.6%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
252
100%
|
261
100%
|
513
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Female |
95
37.7%
|
93
35.6%
|
188
36.6%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles |
|---|---|
| Description | The proportion (percentage) of subjects with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once. |
| Time Frame | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) |
|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 |
| Number (95% Confidence Interval) [Percentage of subjects] |
0.79
|
0.38
|
| Title | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles |
|---|---|
| Description | The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once. |
| Time Frame | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) |
|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 |
| Number (95% Confidence Interval) [Percentage of subjects] |
0.00
|
0.00
|
| Title | Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles |
|---|---|
| Description | The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented. |
| Time Frame | Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Treatment-induced anti-FSH antibodies |
0.79
|
0.38
|
1.05
|
1.08
|
| Antibodies with neutralising capacity |
0.00
|
0.00
|
0.00
|
0.00
|
| Title | Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | The proportion (percentage) of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented. |
| Time Frame | ≤9 days after triggering of final follicular maturation. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intention-to-treat (mITT) analysis set (all exposed subjects). This is equivalent to the full analysis set (FAS). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | Follitropin Alfa (GONAL-F) was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Early OHSS (any grade) |
0.8
|
2.3
|
1.1
|
0.0
|
| Early OHSS (moderate/severe) |
0.0
|
1.9
|
0.0
|
0.0
|
| Any preventive intervention |
1.6
|
1.9
|
0.0
|
1.1
|
| Early OHSS (any grade) / preventive |
2.0
|
3.8
|
1.1
|
1.1
|
| Early OHSS (moderate/severe) / preventive |
1.6
|
3.8
|
0.0
|
1.1
|
| Title | Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Proportion (percentage) of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented. |
| Time Frame | End-of-stimulation (up to 20 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set (all exposed subjects). This is equivalent to the FAS. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Cycle cancelled due to poor ovarian response |
2.0
|
3.8
|
2.1
|
2.2
|
| Cycle cancelled due to excessive ovarian response |
0.4
|
0.0
|
0.0
|
0.0
|
| Triggering with GnRH agonist |
0.4
|
0.8
|
0.0
|
1.1
|
| Title | Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer. |
| Time Frame | 5-6 weeks after blastocyst transfer |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set (all exposed subjects). This is equivalent to the FAS. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Number (95% Confidence Interval) [Percentage of subjects] |
29.4
|
27.2
|
27.4
|
29.0
|
| Title | Implantation Rate for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. |
| Time Frame | 5-6 weeks after blastocyst transfer |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 211 | 221 | 82 | 75 |
| Number (95% Confidence Interval) [Percentage] |
34.6
|
30.6
|
28.8
|
32.2
|
| Title | Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer. |
| Time Frame | 10-11 weeks after blastocyst transfer |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT analysis set (all exposed subjects). This is equivalent to FAS. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Number (95% Confidence Interval) [Percentage of subjects] |
27.8
|
25.7
|
27.4
|
28
|
| Title | Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred. |
| Time Frame | 10-11 weeks after blastocyst transfer |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 211 | 221 | 82 | 75 |
| Number (95% Confidence Interval) [Percentage] |
28.7
|
25.5
|
25.0
|
28.9
|
| Title | Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented. |
| Time Frame | End-of-stimulation (up to 20 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Number [Percentage of events] |
3.0
|
2.4
|
2.8
|
2.3
|
| Title | Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. |
| Time Frame | >9 days after triggering of final follicular maturation |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Late OHSS (any grade) |
0.4
|
0.8
|
1.1
|
1.1
|
| Late OHSS (moderate/severe) |
0.0
|
0.8
|
0.0
|
1.1
|
| Title | Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle |
|---|---|
| Description | Incidences of confirmed technical malfunction of administration pen are presented. |
| Time Frame | End-of-stimulation (up to 20 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis set (all exposed subjects). |
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) |
|---|---|---|---|---|
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. |
| Measure Participants | 252 | 261 | 95 | 93 |
| Number [Percentage of subjects] |
0.0
|
0.0
|
0.0
|
0.0
|
Adverse Events
| Time Frame | Adverse events (AEs) were recorded from signed informed consent to the end-of-cycle visit for COS cycle 2 (up to approximately 4.5 months) and again from screening to the end-of-cycle visit for COS cycle 3 (up to approximately 4.5 months). | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AEs with onset after start of first administration of IMP and before the end-of-cycle were considered treatment-emergent and are presented for the safety analysis set. | |||||||
| Arm/Group Title | FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) | ||||
| Arm/Group Description | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 1. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 18 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 1. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | FE 999049 was administered as single daily subcutaneous injections in the abdomen. The dose was determined based on the ovarian response in COS cycle 2. The daily FE 999049 dose was fixed throughout the stimulation period and maximum allowed daily dose was 24 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | GONAL-F was administered as single daily subcutaneous injections in the abdomen. The starting dose was determined based on the ovarian response in COS cycle 2. The GONAL-F starting dose was fixed for the first 5 days after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 450 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Subjects could be treated for a maximum of 20 days. | ||||
All Cause Mortality |
||||||||
| FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/252 (0%) | 0/261 (0%) | 0/95 (0%) | 0/93 (0%) | ||||
Serious Adverse Events |
||||||||
| FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/252 (1.6%) | 4/261 (1.5%) | 0/95 (0%) | 1/93 (1.1%) | ||||
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Ectopic pregnancy | 1/252 (0.4%) | 1 | 2/261 (0.8%) | 2 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Haemorrhage in pregnancy | 1/252 (0.4%) | 1 | 1/261 (0.4%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Abortion spontaneous | 1/252 (0.4%) | 1 | 0/261 (0%) | 0 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Vomiting in pregnancy | 1/252 (0.4%) | 1 | 0/261 (0%) | 0 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 1/252 (0.4%) | 1 | 0/261 (0%) | 0 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Ovarian hyperstimulation syndrome | 0/252 (0%) | 0 | 1/261 (0.4%) | 1 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| FE 999049 (COS Cycle 2) | GONAL-F (COS Cycle 2) | FE 999049 (COS Cycle 3) | GONAL-F (COS Cycle 3) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 70/252 (27.8%) | 77/261 (29.5%) | 26/95 (27.4%) | 34/93 (36.6%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Procedural pain | 13/252 (5.2%) | 14 | 17/261 (6.5%) | 20 | 5/95 (5.3%) | 6 | 8/93 (8.6%) | 8 |
| Nervous system disorders | ||||||||
| Headache | 19/252 (7.5%) | 24 | 27/261 (10.3%) | 34 | 11/95 (11.6%) | 12 | 13/93 (14%) | 15 |
| Pregnancy, puerperium and perinatal conditions | ||||||||
| Biochemical pregnancy | 13/252 (5.2%) | 13 | 8/261 (3.1%) | 8 | 9/95 (9.5%) | 9 | 4/93 (4.3%) | 4 |
| Haemorrhage in pregnancy | 13/252 (5.2%) | 15 | 10/261 (3.8%) | 11 | 3/95 (3.2%) | 3 | 2/93 (2.2%) | 2 |
| Abortion spontaneous | 10/252 (4%) | 10 | 9/261 (3.4%) | 9 | 5/95 (5.3%) | 5 | 4/93 (4.3%) | 4 |
| Reproductive system and breast disorders | ||||||||
| Pelvic pain | 14/252 (5.6%) | 14 | 11/261 (4.2%) | 12 | 3/95 (3.2%) | 3 | 5/93 (5.4%) | 5 |
| Pelvic discomfort | 6/252 (2.4%) | 6 | 13/261 (5%) | 14 | 0/95 (0%) | 0 | 6/93 (6.5%) | 7 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
| Name/Title | Global Clinical Compliance |
|---|---|
| Organization | Ferring Pharmaceuticals |
| Phone | |
| DK0-Disclosure@ferring.com |
Responsible Party:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01956123
Other Study ID Numbers:
- 000071
- 2013-001616-30
- U1111-1147-6922
First Posted:
Oct 8, 2013
Last Update Posted:
Jul 15, 2021
Last Verified:
Aug 1, 2018