A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01426386
Collaborator
(none)
265
8
6
18
33.1
1.8
Study Details
Study Description
Brief Summary
This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
265 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Mar 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 5.2 µg
|
Drug: FE 999049
|
| Experimental: 6.9 µg
|
Drug: FE 999049
|
| Experimental: 8.6 µg
|
Drug: FE 999049
|
| Experimental: 10.3 µg
|
Drug: FE 999049
|
| Experimental: 12.1 µg
|
Drug: FE 999049
|
| Active Comparator: 11 µg FbM (150 IU)
|
Drug: Gonal - F
|
Outcome Measures
Primary Outcome Measures
- Number of Oocytes Retrieved [Day of oocyte retrieval (up to Day 18 after start of stimulation)]
Secondary Outcome Measures
- Number and Size of Follicles During Stimulation [End of stimulation (up to 16 stimulation days)]
Follicular volume at end of stimulation
- Endocrine Profile [End of stimulation (up to 16 stimulation days)]
Estradiol at end of stimulation
- Total IMP Dose [End of stimulation (up to 16 stimulation days)]
- Number of Fertilised Oocytes [Day 1 after insemination]
An oocyte with 2 pronuclei was regarded as correctly fertilised
- Number and Quality of Blastocysts on Day 5 [Day 5 after oocyte retrieval]
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
- Clinical Pregnancy With Fetal Heart Beat Rate [5-6 weeks after transfer]
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
- Frequency and Intensity of Adverse Events [From signing informed consent form until end of trial visit (up to 5 months)]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 37 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
-
Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
-
Women aged 18-37 years
-
Women with body mass index (BMI) of 18.5-32.0 kg/m2
Exclusion Criteria:
-
Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
-
Women with history of recurrent miscarriage
-
Women with contraindications to controlled ovarian stimulation with gonadotropins
-
Women with three or more controlled ovarian stimulation cycles
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Brussel | Brussels | Belgium | ||
| 2 | UZ Gent | Gent | Belgium | ||
| 3 | ICF CUBE | Prague | Czechia | ||
| 4 | Rigshospitalet | Copenhagen | Denmark | ||
| 5 | IU Dexeus | Barcelona | Spain | ||
| 6 | IVI Madrid | Madrid | Spain | ||
| 7 | IVI Sevilla | Sevilla | Spain | ||
| 8 | IVI Valencia | Valencia | Spain |
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:
NCT01426386
Other Study ID Numbers:
- 000009
- 2011-000633-36
First Posted:
Aug 31, 2011
Last Update Posted:
Nov 17, 2020
Last Verified:
Aug 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 7 sites randomised subjects to the trial: 1 in Belgium, 1 in Czech Republic, 1 in Denmark and 4 in Spain. |
|---|---|
| Pre-assignment Detail | In total 334 subjects were screened. Of these, 69 were screening failures and 265 were randomised. All randomised subjects were exposed to investigational medicinal product (IMP). |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Period Title: Overall Study | ||||||
| STARTED | 42 | 45 | 44 | 44 | 47 | 43 |
| COMPLETED | 39 | 39 | 42 | 44 | 43 | 42 |
| NOT COMPLETED | 3 | 6 | 2 | 0 | 4 | 1 |
Baseline Characteristics
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days | Total of all reporting groups |
| Overall Participants | 42 | 45 | 44 | 44 | 47 | 43 | 265 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
33.6
(2.24)
|
32.3
(3.51)
|
32.8
(2.44)
|
32.3
(3.21)
|
32.6
(2.97)
|
32.4
(3.04)
|
32.7
(2.95)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
42
100%
|
45
100%
|
44
100%
|
44
100%
|
47
100%
|
43
100%
|
265
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of Oocytes Retrieved |
|---|---|
| Description | |
| Time Frame | Day of oocyte retrieval (up to Day 18 after start of stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intention-to-treat (mITT) population (all randomised and exposed subjects). This is equivalent to the Full Analysis Set (FAS) |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Mean (Standard Deviation) [Oocytes] |
5.2
(3.3)
|
7.9
(5.9)
|
9.2
(4.6)
|
10.5
(7.0)
|
12.2
(5.9)
|
10.4
(5.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FE 999049 5.2 µg, FE 999049 6.9 µg, FE 999049 8.6 µg, FE 999049 10.3 µg, FE 999049 12.1 µg |
|---|---|---|
| Comments | The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model | |
| Type of Statistical Test | Other | |
| Comments | Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero) | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | The a priori threshold for statistical significance was 5% (two-sided) | |
| Method | ANCOVA | |
| Comments | Number of oocytes retrieved as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate | |
| Method of Estimation | Estimation Parameter | Slope of the dose-response curve |
| Estimated Value | 7.9 | |
| Confidence Interval |
(2-Sided) 95% 5.69 to 10.18 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number and Size of Follicles During Stimulation |
|---|---|
| Description | Follicular volume at end of stimulation |
| Time Frame | End of stimulation (up to 16 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population (all randomised and exposed subjects). This is equivalent to the FAS |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Mean (Standard Deviation) [cm^3] |
19.2
(7.0)
|
23.0
(10.5)
|
25.0
(9.2)
|
27.9
(15.6)
|
28.2
(9.5)
|
26.7
(9.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FE 999049 5.2 µg, FE 999049 6.9 µg, FE 999049 8.6 µg, FE 999049 10.3 µg, FE 999049 12.1 µg |
|---|---|---|
| Comments | The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model | |
| Type of Statistical Test | Other | |
| Comments | Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero) | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | No adjustment for multiplicity was applied for the secondary endpoints | |
| Method | ANCOVA | |
| Comments | Follicular volume as dependent variable, centre and AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factors and log(dose) as covariate | |
| Method of Estimation | Estimation Parameter | Slope of the dose-response curve |
| Estimated Value | 11.1 | |
| Confidence Interval |
(2-Sided) 95% 6.78 to 15.48 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Endocrine Profile |
|---|---|
| Description | Estradiol at end of stimulation |
| Time Frame | End of stimulation (up to 16 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population (all randomised and exposed subjects). This is equivalent to the FAS |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Mean (Standard Deviation) [pmol/L] |
3641.9
(2954.6)
|
5221.1
(3378.8)
|
5689.5
(3995.7)
|
6171.8
(3855.9)
|
6442.0
(3195.2)
|
5750.7
(3709.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FE 999049 5.2 µg, FE 999049 6.9 µg, FE 999049 8.6 µg, FE 999049 10.3 µg, FE 999049 12.1 µg |
|---|---|---|
| Comments | The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model | |
| Type of Statistical Test | Other | |
| Comments | Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero) | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | No adjustment for multiplicity was applied for the secondary endpoints | |
| Method | ANCOVA | |
| Comments | Log(estradiol) as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor, log(dose) and log(baseline estradiol) as covariates | |
| Method of Estimation | Estimation Parameter | Slope of the dose-response curve |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 95% 0.56 to 1.11 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Total IMP Dose |
|---|---|
| Description | |
| Time Frame | End of stimulation (up to 16 stimulation days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population (all randomised and exposed subjects). This is equivalent to the FAS |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Mean (Standard Deviation) [µg] |
50.0
(11.6)
|
61.9
(13.7)
|
71.9
(14.1)
|
81.0
(14.2)
|
97.8
(22.0)
|
94.7
(18.1)
|
| Title | Number of Fertilised Oocytes |
|---|---|
| Description | An oocyte with 2 pronuclei was regarded as correctly fertilised |
| Time Frame | Day 1 after insemination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with oocytes retrieved |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Mean (Standard Deviation) [Fertilised oocytes] |
3.7
(2.5)
|
5.4
(3.8)
|
4.9
(2.7)
|
6.1
(5.1)
|
6.7
(3.5)
|
6.4
(3.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FE 999049 5.2 µg, FE 999049 6.9 µg, FE 999049 8.6 µg, FE 999049 10.3 µg, FE 999049 12.1 µg |
|---|---|---|
| Comments | The dose-response relationship was analysed using an analysis of covariance (ANCOVA) model | |
| Type of Statistical Test | Other | |
| Comments | Based on the ANCOVA model the slope of the dose-response curve was estimated. Null hypothesis: Slope of dose-response curve equal to 0 (zero) | |
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | No adjustment for multiplicity was applied for the secondary endpoints | |
| Method | ANCOVA | |
| Comments | Fertilised oocytes as dependent variable, AMH strata (5.0-14.9 pmol/L and 15.0-44.9 pmol/L) as factor and log(dose) as covariate | |
| Method of Estimation | Estimation Parameter | Slope of the dose-response curve |
| Estimated Value | 3.2 | |
| Confidence Interval |
(2-Sided) 95% 1.71 to 4.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number and Quality of Blastocysts on Day 5 |
|---|---|
| Description | Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher |
| Time Frame | Day 5 after oocyte retrieval |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with oocytes retrieved |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Total blastocysts |
2.3
(1.7)
|
3.1
(2.7)
|
2.7
(2.0)
|
2.8
(2.8)
|
3.2
(2.2)
|
3.5
(2.5)
|
| Good quality blastocysts |
0.9
(1.2)
|
1.4
(1.7)
|
1.2
(1.2)
|
1.4
(1.5)
|
1.3
(1.3)
|
1.6
(1.6)
|
| Title | Clinical Pregnancy With Fetal Heart Beat Rate |
|---|---|
| Description | Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat |
| Time Frame | 5-6 weeks after transfer |
Outcome Measure Data
| Analysis Population Description |
|---|
| mITT population (all randomised and exposed subjects). This is equivalent to the FAS |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Number (95% Confidence Interval) [percentage] |
36
|
40
|
36
|
25
|
40
|
51
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | FE 999049 5.2 µg, FE 999049 6.9 µg, FE 999049 8.6 µg, FE 999049 10.3 µg, FE 999049 12.1 µg, GONAL-F 11 µg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Treatment groups were compared using the chi-squared test. | |
| Statistical Test of Hypothesis | p-Value | 0.248 |
| Comments | No adjustment for multiplicity was applied for the secondary endpoints | |
| Method | Chi-squared | |
| Comments | ||
| Title | Frequency and Intensity of Adverse Events |
|---|---|
| Description | |
| Time Frame | From signing informed consent form until end of trial visit (up to 5 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population (all randomised and exposed subjects). This is equivalent to the mITT |
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days |
| Measure Participants | 42 | 45 | 44 | 44 | 47 | 43 |
| Any mild adverse events |
15
35.7%
|
17
37.8%
|
17
38.6%
|
18
40.9%
|
15
31.9%
|
11
25.6%
|
| Any moderate adverse events |
2
4.8%
|
6
13.3%
|
5
11.4%
|
9
20.5%
|
8
17%
|
2
4.7%
|
| Any severe adverse events |
0
0%
|
0
0%
|
0
0%
|
1
2.3%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | From signing informed consent form until the end of trial visit (up to 5 months) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg | ||||||
| Arm/Group Description | Subjects received single daily subcutaneous injections of 5.2 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 6.9 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 8.6 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 10.3 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 12.1 µg FE 999049, for a maximum of 16 days | Subjects received single daily subcutaneous injections of 11 µg GONAL-F, for a maximum of 16 days | ||||||
All Cause Mortality |
||||||||||||
| FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/45 (0%) | 0/44 (0%) | 0/44 (0%) | 0/47 (0%) | 0/43 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/42 (0%) | 0/45 (0%) | 0/44 (0%) | 1/44 (2.3%) | 0/47 (0%) | 0/43 (0%) | ||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||
| Ectopic pregnancy | 0/42 (0%) | 0 | 0/45 (0%) | 0 | 0/44 (0%) | 0 | 1/44 (2.3%) | 1 | 0/47 (0%) | 0 | 0/43 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| FE 999049 5.2 µg | FE 999049 6.9 µg | FE 999049 8.6 µg | FE 999049 10.3 µg | FE 999049 12.1 µg | GONAL-F 11 µg | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/42 (26.2%) | 9/45 (20%) | 11/44 (25%) | 12/44 (27.3%) | 11/47 (23.4%) | 4/43 (9.3%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Nausea | 2/42 (4.8%) | 2 | 0/45 (0%) | 0 | 0/44 (0%) | 0 | 1/44 (2.3%) | 1 | 4/47 (8.5%) | 4 | 0/43 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Headache | 4/42 (9.5%) | 4 | 4/45 (8.9%) | 4 | 5/44 (11.4%) | 5 | 3/44 (6.8%) | 4 | 1/47 (2.1%) | 1 | 1/43 (2.3%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||||
| Abortion spontaneous | 3/42 (7.1%) | 3 | 5/45 (11.1%) | 5 | 2/44 (4.5%) | 2 | 5/44 (11.4%) | 5 | 5/47 (10.6%) | 5 | 1/43 (2.3%) | 1 |
| Reproductive system and breast disorders | ||||||||||||
| Vaginal haemorrhage | 2/42 (4.8%) | 2 | 1/45 (2.2%) | 1 | 4/44 (9.1%) | 4 | 3/44 (6.8%) | 4 | 2/47 (4.3%) | 2 | 1/43 (2.3%) | 1 |
| Pelvic pain | 2/42 (4.8%) | 2 | 0/45 (0%) | 0 | 1/44 (2.3%) | 1 | 3/44 (6.8%) | 3 | 2/47 (4.3%) | 2 | 2/43 (4.7%) | 2 |
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:
NCT01426386
Other Study ID Numbers:
- 000009
- 2011-000633-36
First Posted:
Aug 31, 2011
Last Update Posted:
Nov 17, 2020
Last Verified:
Aug 1, 2018