Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00511199
Collaborator
(none)
2,152
2
23
Study Details
Study Description
Brief Summary
The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2152 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)
Actual Study Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Apr 1, 2008
Actual Study Completion Date
:
Apr 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NOMAC-E2 Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive |
Drug: NOMAC-E2
Nomegestrol Acetate and Estradiol Tablets, 2.5 mg
NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
Other Names:
|
| Active Comparator: DRSP-EE Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive |
Drug: DRSP-EE
Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [1 year (13 cycles)]
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
- Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) [1 year (13 cycles)]
In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Secondary Outcome Measures
- Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
- Number of Participants With an Occurrence of Absence of Withdrawal Bleeding [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
- Number of Participants With an Occurrence of Breakthrough Bleeding [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
- Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
- Number of Participants With an Occurrence of Early Withdrawal Bleeding [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
- Number of Participants With an Occurrence of Continued Withdrawal Bleeding [Every 28-day cycle for 12 cycles]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
- Average Number of Breakthrough Bleeding/Spotting Days [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.
- Average Number of Withdrawal Bleeding/Spotting Days [Every 28-day cycle for 13 cycles (one year total)]
Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Sexually active women, at risk for pregnancy and not planning to use condoms.
-
Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles).
-
At least 18 but not older than 50 years of age at the time of screening.
-
Body mass index (BMI) of >/= 17 and </= 35.
-
Good physical and mental health.
-
Willing to give informed consent in writing.
Exclusion Criteria:
-
Contraindications for contraceptive steroids.
-
In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional
contraindications related to the antimineralocorticoid activity of drospirenone
(conditions that predispose to hyperkalemia):
-
Renal insufficiency
-
Hepatic dysfunction
-
Adrenal insufficiency
-
An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN],
Squamous Intraepithelial Lesion [SIL], carcinoma in situ, invasive carcinoma) at screening.
-
Clinically relevant abnormal laboratory result at screening as judged by the investigator.
-
Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.
-
Before spontaneous menstruation has occurred following a delivery or abortion.
-
Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
-
Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).
-
Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00511199
Other Study ID Numbers:
- P05724
- Organon Protocol No. 292001
First Posted:
Aug 3, 2007
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Study Results
Participant Flow
| Recruitment Details | This study recruited participants from Europe, Asia and Australia. |
|---|---|
| Pre-assignment Detail | In total, 2152 subjects were randomized, of which 1613 subjects to NOMAC-E2 and 539 subjects to DRSP-EE. A total of 2126 subjects were randomized and treated, of which 1591 subjects on NOMAC-E2 and 535 subjects on DRSP-EE. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Period Title: Overall Study | ||
| STARTED | 1591 | 535 |
| COMPLETED | 1142 | 410 |
| NOT COMPLETED | 449 | 125 |
Baseline Characteristics
| Arm/Group Title | NOMAC-E2 | DRSP-EE | Total |
|---|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Total of all reporting groups |
| Overall Participants | 1591 | 535 | 2126 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
28.1
(7.0)
|
27.6
(7.0)
|
28.0
(7.0)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1591
100%
|
535
100%
|
2126
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
|---|---|
| Description | In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant. |
| Time Frame | 1 year (13 cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data). |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1442 | 486 |
| Measure woman years (rounded to nearest integer) | 857 | 295 |
| Overall group |
0.467
|
1.017
|
| =<35 years old (n= 1193; n=402) |
0.571
|
1.261
|
| >35 years old (n= 249; n=84) |
0.000
|
0.000
|
| Title | Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) |
|---|---|
| Description | In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a period of 14 days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant. |
| Time Frame | 1 year (13 cycles) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Restricted ITT set included all participants treated except for 2 nonpregnant participants whose exposure was excluded due to limited credibility of diary data & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o confirmed sexual intercourse, based on e-diary data). |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1442 | 486 |
| Measure woman years (rounded to nearest integer) | 857 | 295 |
| Overall group |
0.817
|
1.356
|
| =<35 years old (n=1193; n=402) |
0.999
|
1.682
|
| >35 years old (n=249; n=84) |
0.000
|
0.000
|
| Title | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE) |
483
30.4%
|
130
24.3%
|
| Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE) |
289
18.2%
|
75
14%
|
| Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE) |
297
18.7%
|
54
10.1%
|
| Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE) |
231
14.5%
|
59
11%
|
| Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE) |
221
13.9%
|
62
11.6%
|
| Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE) |
182
11.4%
|
53
9.9%
|
| Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE) |
165
10.4%
|
45
8.4%
|
| Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE) |
127
8%
|
47
8.8%
|
| Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE) |
129
8.1%
|
47
8.8%
|
| Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE) |
121
7.6%
|
32
6%
|
| Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE) |
125
7.9%
|
29
5.4%
|
| Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE) |
110
6.9%
|
30
5.6%
|
| Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE) |
94
5.9%
|
33
6.2%
|
| Title | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Absence of withdrawal bleeding was defined as no bleeding/spotting episode that began during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE) |
284
17.9%
|
14
2.6%
|
| Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE) |
237
14.9%
|
17
3.2%
|
| Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE) |
258
16.2%
|
18
3.4%
|
| Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE) |
244
15.3%
|
20
3.7%
|
| Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE) |
245
15.4%
|
17
3.2%
|
| Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE) |
249
15.7%
|
10
1.9%
|
| Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE) |
245
15.4%
|
11
2.1%
|
| Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE) |
235
14.8%
|
9
1.7%
|
| Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE) |
245
15.4%
|
13
2.4%
|
| Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE) |
245
15.4%
|
12
2.2%
|
| Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE) |
232
14.6%
|
17
3.2%
|
| Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE) |
227
14.3%
|
12
2.2%
|
| Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE) |
279
17.5%
|
14
2.6%
|
| Title | Number of Participants With an Occurrence of Breakthrough Bleeding |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding was defined as any bleeding episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: LNG-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE) |
129
8.1%
|
24
4.5%
|
| Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE) |
63
4%
|
20
3.7%
|
| Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE) |
61
3.8%
|
16
3%
|
| Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE) |
54
3.4%
|
11
2.1%
|
| Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE) |
52
3.3%
|
12
2.2%
|
| Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE) |
43
2.7%
|
8
1.5%
|
| Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE) |
41
2.6%
|
7
1.3%
|
| Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE) |
28
1.8%
|
5
0.9%
|
| Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE) |
32
2%
|
7
1.3%
|
| Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE) |
23
1.4%
|
7
1.3%
|
| Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE) |
27
1.7%
|
7
1.3%
|
| Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE) |
30
1.9%
|
13
2.4%
|
| Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE) |
21
1.3%
|
12
2.2%
|
| Title | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough spotting was defined as any spotting episode that occurred during the "expected non-bleeding period" that was neither part of an early nor continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE) |
408
25.6%
|
118
22.1%
|
| Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE) |
244
15.3%
|
58
10.8%
|
| Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE) |
257
16.2%
|
42
7.9%
|
| Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE) |
186
11.7%
|
51
9.5%
|
| Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE) |
180
11.3%
|
52
9.7%
|
| Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE) |
148
9.3%
|
45
8.4%
|
| Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE) |
135
8.5%
|
40
7.5%
|
| Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE) |
104
6.5%
|
43
8%
|
| Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE) |
106
6.7%
|
40
7.5%
|
| Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE) |
105
6.6%
|
27
5%
|
| Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE) |
100
6.3%
|
22
4.1%
|
| Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE) |
87
5.5%
|
18
3.4%
|
| Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE) |
76
4.8%
|
22
4.1%
|
| Title | Number of Participants With an Occurrence of Early Withdrawal Bleeding |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Early withdrawal bleeding was defined as any withdrawal bleeding that started before the current "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants with evaluable cycles. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1466 NOMAC-E2; n=470 DRSP-EE) |
142
8.9%
|
52
9.7%
|
| Cycle 2 (n=1339 NOMAC-E2; n=440 DRSP-EE) |
93
5.8%
|
29
5.4%
|
| Cycle 3 (n=1233 NOMAC-E2; n=398 DRSP-EE) |
80
5%
|
22
4.1%
|
| Cycle 4 (n=1135 NOMAC-E2; n=389 DRSP-EE) |
69
4.3%
|
20
3.7%
|
| Cycle 5 (n=1064 NOMAC-E2; n=368 DRSP-EE) |
55
3.5%
|
22
4.1%
|
| Cycle 6 (n=982 NOMAC-E2; n=349 DRSP-EE) |
34
2.1%
|
16
3%
|
| Cycle 7 (n=931 NOMAC-E2; n=320 DRSP-EE) |
36
2.3%
|
18
3.4%
|
| Cycle 8 (n=874 NOMAC-E2; n=298 DRSP-EE) |
31
1.9%
|
12
2.2%
|
| Cycle 9 (n=861 NOMAC-E2; n=295 DRSP-EE) |
33
2.1%
|
11
2.1%
|
| Cycle 10 (n=809 NOMAC-E2; n=271 DRSP-EE) |
19
1.2%
|
9
1.7%
|
| Cycle 11 (n=770 NOMAC-E2; n=277 DRSP-EE) |
27
1.7%
|
9
1.7%
|
| Cycle 12 (n=743 NOMAC-E2; n=259 DRSP-EE) |
18
1.1%
|
9
1.7%
|
| Cycle 13 (n=666 NOMAC-E2; n=241 DRSP-EE) |
17
1.1%
|
8
1.5%
|
| Title | Number of Participants With an Occurrence of Continued Withdrawal Bleeding |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Time Frame | Every 28-day cycle for 12 cycles |
Outcome Measure Data
| Analysis Population Description |
|---|
| The ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1455 NOMAC-E2; n=466 DRSP-EE) |
412
25.9%
|
283
52.9%
|
| Cycle 2 (n=1320 NOMAC-E2; n=437 DRSP-EE) |
406
25.5%
|
274
51.2%
|
| Cycle 3 (n=1201 NOMAC-E2; n=397 DRSP-EE) |
364
22.9%
|
243
45.4%
|
| Cycle 4 (n=1120 NOMAC-E2; n=387 DRSP-EE) |
321
20.2%
|
222
41.5%
|
| Cycle 5 (n=1051 NOMAC-E2; n=365 DRSP-EE) |
280
17.6%
|
203
37.9%
|
| Cycle 6 (n=965 NOMAC-E2; n=348 DRSP-EE) |
285
17.9%
|
190
35.5%
|
| Cycle 7 (n=920 NOMAC-E2; n=318 DRSP-EE) |
247
15.5%
|
190
35.5%
|
| Cycle 8 (n=868 NOMAC-E2; n=296 DRSP-EE) |
224
14.1%
|
170
31.8%
|
| Cycle 9 (n=854 NOMAC-E2; n=291 DRSP-EE) |
228
14.3%
|
176
32.9%
|
| Cycle 10 (n=806 NOMAC-E2; n=269 DRSP-EE) |
191
12%
|
158
29.5%
|
| Cycle 11 (n=766 NOMAC-E2; n=276 DRSP-EE) |
195
12.3%
|
162
30.3%
|
| Cycle 12 (n=725 NOMAC-E2; n=257 DRSP-EE) |
184
11.6%
|
153
28.6%
|
| Title | Average Number of Breakthrough Bleeding/Spotting Days |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Breakthrough bleeding/spotting was defined as any episode that occurred during the "expected non-bleeding period" that was neither an early nor a continued withdrawal bleeding. Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had breakthrough bleeding/spotting for the respective cycle. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=483 NOMAC-E2; n=130 DRSP-EE) |
4.6
(3.6)
|
4.2
(3.0)
|
| Cycle 2 (n=289 NOMAC-E2; n=75 DRSP-EE) |
3.5
(2.8)
|
3.2
(2.5)
|
| Cycle 3 (n=297 NOMAC-E2; n=54 DRSP-EE) |
3.4
(2.6)
|
3.6
(2.8)
|
| Cycle 4 (n=231 NOMAC-E2; n=59 DRSP-EE) |
3.1
(2.5)
|
2.9
(2.5)
|
| Cycle 5 (n=221 NOMAC-E2; n=62 DRSP-EE) |
3.2
(2.5)
|
2.9
(2.8)
|
| Cycle 6 (n=182 NOMAC-E2; n=53 DRSP-EE) |
3.3
(2.5)
|
2.4
(2.0)
|
| Cycle 7 (n=165 NOMAC-E2; n=45 DRSP-EE) |
3.2
(2.5)
|
3.0
(2.8)
|
| Cycle 8 (n=127 NOMAC-E2; n=47 DRSP-EE) |
3.1
(2.4)
|
2.7
(1.9)
|
| Cycle 9 (n=129 NOMAC-E2; n=47 DRSP-EE) |
3.4
(2.6)
|
2.6
(2.2)
|
| Cycle 10 (n=121 NOMAC-E2; n=32 DRSP-EE) |
3.1
(2.5)
|
3.1
(2.6)
|
| Cycle 11 (n=125 NOMAC-E2; n=29 DRSP-EE) |
2.8
(2.4)
|
2.6
(2.5)
|
| Cycle 12 (n=110 NOMAC-E2; n=30 DRSP-EE) |
3.1
(2.2)
|
2.6
(2.3)
|
| Cycle 13 (n=94 NOMAC-E2; n=33 DRSP-EE) |
2.7
(2.0)
|
3.2
(2.6)
|
| Title | Average Number of Withdrawal Bleeding/Spotting Days |
|---|---|
| Description | Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Withdrawal bleeding was defined as bleeding/spotting episode that started during or continued into the "expected bleeding period". Expected bleeding period: DRSP-EE group: 7-day period starting on Day 22 of the cycle; NOMAC-E2: 7-day period starting on Day 25 of the cycle and ending on Day 3 of the next cycle. |
| Time Frame | Every 28-day cycle for 13 cycles (one year total) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length. n= number of participants who had withdrawal bleeding/spotting for the respective cycle. |
| Arm/Group Title | NOMAC-E2 | DRSP-EE |
|---|---|---|
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). |
| Measure Participants | 1524 | 503 |
| Cycle 1 (n=1182 NOMAC-E2; n=456 DRSP-EE) |
5.7
(11.2)
|
6.0
(3.3)
|
| Cycle 2 (n=1102 NOMAC-E2; n=423 DRSP-EE) |
5.6
(15.1)
|
5.5
(2.2)
|
| Cycle 3 (n=975 NOMAC-E2; n=380 DRSP-EE) |
5.9
(19.0)
|
5.4
(2.4)
|
| Cycle 4 (n=891 NOMAC-E2; n=369 DRSP-EE) |
6.0
(19.9)
|
5.4
(3.5)
|
| Cycle 5 (n=819 NOMAC-E2; n=351 DRSP-EE) |
6.0
(20.8)
|
5.3
(3.4)
|
| Cycle 6 (n=733 NOMAC-E2; n=339 DRSP-EE) |
5.8
(21.8)
|
5.2
(2.8)
|
| Cycle 7 (n=686 NOMAC-E2; n=309 DRSP-EE) |
5.8
(22.4)
|
5.2
(2.5)
|
| Cycle 8 (n=639 NOMAC-E2; n=289 DRSP-EE) |
5.6
(22.3)
|
5.7
(8.5)
|
| Cycle 9 (n=616 NOMAC-E2; n=282 DRSP-EE) |
5.7
(21.9)
|
5.7
(8.5)
|
| Cycle 10 (n=564 NOMAC-E2; n=259 DRSP-EE) |
5.7
(23.5)
|
5.5
(8.2)
|
| Cycle 11 (n=538 NOMAC-E2; n=260 DRSP-EE) |
6.0
(24.1)
|
5.6
(8.3)
|
| Cycle 12 (n=516 NOMAC-E2; n=247 DRSP-EE) |
5.6
(21.3)
|
5.7
(8.9)
|
| Cycle 13 (n=387 NOMAC-E2; n=227 DRSP-EE) |
4.9
(23.9)
|
4.2
(3.8)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | NOMAC-E2 | DRSP-EE | ||
| Arm/Group Description | Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year). | ||
All Cause Mortality |
||||
| NOMAC-E2 | DRSP-EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| NOMAC-E2 | DRSP-EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/1591 (2.4%) | 13/535 (2.4%) | ||
| Ear and labyrinth disorders | ||||
| Vestibular neuronitis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/1591 (0.1%) | 1 | 1/535 (0.2%) | 1 |
| Anal fissure | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Constipation | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Enteritis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Haemorrhoids | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Mesenteric vein thrombosis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Nausea | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| General disorders | ||||
| Fatigue | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Pyrexia | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholelithiasis | 2/1591 (0.1%) | 2 | 0/535 (0%) | 0 |
| Portal vein thrombosis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Infections and infestations | ||||
| Appendicitis | 1/1591 (0.1%) | 1 | 1/535 (0.2%) | 1 |
| Cellulitis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Cryptosporidiosis infection | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Encephalitis viral | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Epiglottitis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Gastroenteritis | 3/1591 (0.2%) | 3 | 0/535 (0%) | 0 |
| Giardiasis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Peritonsillar abscess | 2/1591 (0.1%) | 2 | 0/535 (0%) | 0 |
| Pilonidal cyst | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Pyelonephritis | 1/1591 (0.1%) | 1 | 1/535 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Alcohol poisoning | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Fibula fracture | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Ligament injury | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Limb injury | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Multiple injuries | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Tibia fracture | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Exostosis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Intervertebral disc disorder | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Intervertebral disc protrusion | 3/1591 (0.2%) | 3 | 1/535 (0.2%) | 1 |
| Myalgia | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Osteonecrosis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Systemic lupus erythematosus | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Tenosynovitis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Colon cancer metastatic | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Metastatic gastric cancer | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
| Multiple Sclerosis | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Hyperemesis gravidarum | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Haematosalpinx | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Menorrhagia | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Hyperventilation | 1/1591 (0.1%) | 1 | 0/535 (0%) | 0 |
| Nasal septum deviation | 2/1591 (0.1%) | 2 | 0/535 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 0/1591 (0%) | 0 | 1/535 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| NOMAC-E2 | DRSP-EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 849/1591 (53.4%) | 242/535 (45.2%) | ||
| Infections and infestations | ||||
| Influenza | 55/1591 (3.5%) | 61 | 30/535 (5.6%) | 36 |
| Nasopharyngitis | 144/1591 (9.1%) | 190 | 53/535 (9.9%) | 66 |
| Vaginal candidiasis | 127/1591 (8%) | 143 | 45/535 (8.4%) | 53 |
| Investigations | ||||
| Weight increased | 158/1591 (9.9%) | 162 | 37/535 (6.9%) | 38 |
| Nervous system disorders | ||||
| Headache | 217/1591 (13.6%) | 405 | 72/535 (13.5%) | 123 |
| Reproductive system and breast disorders | ||||
| Cervical dysplasia | 111/1591 (7%) | 112 | 39/535 (7.3%) | 40 |
| Withdrawal bleeding irregular | 188/1591 (11.8%) | 424 | 2/535 (0.4%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 280/1591 (17.6%) | 335 | 47/535 (8.8%) | 53 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The SPONSOR recognizes the right of the investigator(s) to publish, but all publications must be based on data validated and released by the SPONSOR. Any such scientific paper, presentation, or other communication concerning the clinical trial will first be submitted to the SPONSOR, at least six weeks ahead of estimated publication or presentation, for consent, which shall not be withheld unreasonably.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | |
| ClinicalTrialsDisclosure@merck.com |
Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00511199
Other Study ID Numbers:
- P05724
- Organon Protocol No. 292001
First Posted:
Aug 3, 2007
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022