Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(P05722)
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
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: 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 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
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 >=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.
-
Subjects with a diagnosis of the endometrial biopsy such as hyperplasia, atypical hyperplasia, carcinoma or any other abnormality judged clinically relevant by the investigator (This is applicable only for the subjects participating in the endometrial biopsy substudy).
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.- P05722
- 292002
Study Results
Participant Flow
| Recruitment Details | This study recruited participants from North America and South America |
|---|---|
| Pre-assignment Detail | In total, 2281 participants were randomized (NOMAC-E2 n=1710; DRSP-EE n=571) but 2220 participants were treated (NOMAC-E2 n=1666; DRSP-EE n=554). |
| 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 | 1666 | 554 |
| COMPLETED | 988 | 344 |
| NOT COMPLETED | 678 | 210 |
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 | 1666 | 554 | 2220 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
27.6
(7.2)
|
27.8
(7.0)
|
27.7
(7.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1666
100%
|
554
100%
|
2220
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 |
|---|
| The "restricted ITT" set included all participants treated except for 27 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 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 | 1370 | 444 |
| Measure woman years (rounded to nearest integer) | 684 | 233 |
| Overall group |
1.754
|
3.005
|
| =<35 years old (n=1158; n=378) |
1.963
|
3.092
|
| >35 years old (n=212; n=66) |
0.807
|
2.572
|
| 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 | 1312 | 436 |
| Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE) |
370
22.2%
|
84
15.2%
|
| Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE) |
243
14.6%
|
55
9.9%
|
| Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE) |
196
11.8%
|
40
7.2%
|
| Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE) |
152
9.1%
|
34
6.1%
|
| Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE) |
139
8.3%
|
29
5.2%
|
| Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE) |
125
7.5%
|
18
3.2%
|
| Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE) |
104
6.2%
|
25
4.5%
|
| Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE) |
97
5.8%
|
23
4.2%
|
| Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE) |
85
5.1%
|
30
5.4%
|
| Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE) |
93
5.6%
|
29
5.2%
|
| Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE) |
83
5%
|
27
4.9%
|
| Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE) |
70
4.2%
|
15
2.7%
|
| Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE) |
62
3.7%
|
20
3.6%
|
| 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 |
|---|
| The "restricted ITT" set included all participants treated except for 27 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 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 | 1370 | 444 |
| Measure woman years (rounded to nearest integer) | 684 | 233 |
| Overall group |
2.192
|
4.293
|
| =<35 years old (n=1158; n=378) |
2.498
|
4.638
|
| >35 years old (n=212; n=66) |
0.807
|
2.572
|
| 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 | 1312 | 436 |
| Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE) |
216
13%
|
23
4.2%
|
| Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE) |
167
10%
|
15
2.7%
|
| Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE) |
178
10.7%
|
15
2.7%
|
| Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE) |
184
11%
|
16
2.9%
|
| Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE) |
169
10.1%
|
13
2.3%
|
| Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE) |
166
10%
|
9
1.6%
|
| Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE) |
139
8.3%
|
13
2.3%
|
| Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE) |
152
9.1%
|
16
2.9%
|
| Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE) |
151
9.1%
|
8
1.4%
|
| Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE) |
147
8.8%
|
8
1.4%
|
| Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE) |
156
9.4%
|
6
1.1%
|
| Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE) |
141
8.5%
|
10
1.8%
|
| Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE) |
187
11.2%
|
7
1.3%
|
| 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: 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 | 1312 | 436 |
| Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE) |
100
6%
|
19
3.4%
|
| Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE) |
47
2.8%
|
5
0.9%
|
| Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE) |
43
2.6%
|
5
0.9%
|
| Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE) |
39
2.3%
|
7
1.3%
|
| Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE) |
30
1.8%
|
4
0.7%
|
| Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE) |
29
1.7%
|
4
0.7%
|
| Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE) |
31
1.9%
|
5
0.9%
|
| Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE) |
25
1.5%
|
5
0.9%
|
| Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE) |
24
1.4%
|
7
1.3%
|
| Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE) |
27
1.6%
|
9
1.6%
|
| Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE) |
19
1.1%
|
5
0.9%
|
| Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE) |
16
1%
|
3
0.5%
|
| Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE) |
16
1%
|
2
0.4%
|
| 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 | 1312 | 436 |
| Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE) |
306
18.4%
|
72
13%
|
| Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE) |
211
12.7%
|
50
9%
|
| Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE) |
168
10.1%
|
36
6.5%
|
| Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE) |
126
7.6%
|
30
5.4%
|
| Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE) |
114
6.8%
|
25
4.5%
|
| Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE) |
102
6.1%
|
16
2.9%
|
| Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE) |
85
5.1%
|
20
3.6%
|
| Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE) |
78
4.7%
|
18
3.2%
|
| Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE) |
64
3.8%
|
23
4.2%
|
| Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE) |
71
4.3%
|
21
3.8%
|
| Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE) |
67
4%
|
22
4%
|
| Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE) |
59
3.5%
|
12
2.2%
|
| Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE) |
46
2.8%
|
18
3.2%
|
| 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 | 1312 | 436 |
| Cycle 1 (n=1202 NOMAC-E2; n=398 DRSP-EE) |
175
10.5%
|
46
8.3%
|
| Cycle 2 (n=950 NOMAC-E2; n=308 DRSP-EE) |
68
4.1%
|
14
2.5%
|
| Cycle 3 (n=812 NOMAC-E2; n=256 DRSP-EE) |
66
4%
|
24
4.3%
|
| Cycle 4 (n=739 NOMAC-E2; n=236 DRSP-EE) |
48
2.9%
|
9
1.6%
|
| Cycle 5 (n=671 NOMAC-E2; n=229 DRSP-EE) |
36
2.2%
|
11
2%
|
| Cycle 6 (n=628 NOMAC-E2; n=207 DRSP-EE) |
28
1.7%
|
11
2%
|
| Cycle 7 (n=565 NOMAC-E2; n=196 DRSP-EE) |
22
1.3%
|
11
2%
|
| Cycle 8 (n=543 NOMAC-E2; n=189 DRSP-EE) |
29
1.7%
|
13
2.3%
|
| Cycle 9 (n=507 NOMAC-E2; n=173 DRSP-EE) |
17
1%
|
9
1.6%
|
| Cycle 10 (n=491 NOMAC-E2; n=170 DRSP-EE) |
27
1.6%
|
13
2.3%
|
| Cycle 11 (n=456 NOMAC-E2; n=160 DRSP-EE) |
17
1%
|
7
1.3%
|
| Cycle 12 (n=428 NOMAC-E2; n=152 DRSP-EE) |
10
0.6%
|
6
1.1%
|
| Cycle 13 (n=383 NOMAC-E2; n=133 DRSP-EE) |
9
0.5%
|
6
1.1%
|
| 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 | 1312 | 436 |
| Cycle 1 (n=1179 NOMAC-E2; n=393 DRSP-EE) |
367
22%
|
216
39%
|
| Cycle 2 (n=939 NOMAC-E2; n=304 DRSP-EE) |
309
18.5%
|
174
31.4%
|
| Cycle 3 (n=794 NOMAC-E2; n=254 DRSP-EE) |
225
13.5%
|
149
26.9%
|
| Cycle 4 (n=730 NOMAC-E2; n=235 DRSP-EE) |
192
11.5%
|
145
26.2%
|
| Cycle 5 (n=659 NOMAC-E2; n=227 DRSP-EE) |
171
10.3%
|
135
24.4%
|
| Cycle 6 (n=617 NOMAC-E2; n=207 DRSP-EE) |
149
8.9%
|
122
22%
|
| Cycle 7 (n=555 NOMAC-E2; n=194 DRSP-EE) |
142
8.5%
|
111
20%
|
| Cycle 8 (n=540 NOMAC-E2; n=188 DRSP-EE) |
128
7.7%
|
107
19.3%
|
| Cycle 9 (n=503 NOMAC-E2; n=171 DRSP-EE) |
116
7%
|
106
19.1%
|
| Cycle 10 (n=486 NOMAC-E2; n=169 DRSP-EE) |
121
7.3%
|
95
17.1%
|
| Cycle 11 (n=455 NOMAC-E2; n=159 DRSP-EE) |
90
5.4%
|
94
17%
|
| Cycle 12 (n=421 NOMAC-E2; n=149 DRSP-EE) |
95
5.7%
|
78
14.1%
|
| 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 | 1312 | 436 |
| Cycle 1 (n=370 NOMAC-E2; n=84 DRSP-EE) |
4.5
(3.6)
|
4.0
(2.9)
|
| Cycle 2 (n=243 NOMAC-E2; n=55 DRSP-EE) |
3.5
(2.7)
|
2.7
(2.3)
|
| Cycle 3 (n=196 NOMAC-E2; n=40 DRSP-EE) |
3.2
(2.5)
|
2.6
(2.0)
|
| Cycle 4 (n=152 NOMAC-E2; n=34 DRSP-EE) |
3.5
(2.7)
|
3.2
(2.5)
|
| Cycle 5 (n=139 NOMAC-E2; n=29 DRSP-EE) |
3.6
(3.0)
|
2.6
(2.1)
|
| Cycle 6 (n=125 NOMAC-E2; n=18 DRSP-EE) |
3.2
(2.7)
|
3.0
(1.7)
|
| Cycle 7 (n=104 NOMAC-E2; n=25 DRSP-EE) |
3.9
(2.9)
|
2.9
(2.0)
|
| Cycle 8 (n=97 NOMAC-E2; n=23 DRSP-EE) |
3.4
(2.4)
|
2.6
(2.4)
|
| Cycle 9 (n=85 NOMAC-E2; n=30 DRSP-EE) |
3.5
(3.2)
|
3.2
(2.2)
|
| Cycle 10 (n=93 NOMAC-E2; n=29 DRSP-EE) |
2.6
(2.1)
|
3.2
(2.1)
|
| Cycle 11 (n=83 NOMAC-E2; n=27 DRSP-EE) |
3.6
(2.5)
|
2.9
(2.0)
|
| Cycle 12 (n=70 NOMAC-E2; n=15 DRSP-EE) |
2.9
(2.4)
|
3.1
(2.9)
|
| Cycle 13 (n=62 NOMAC-E2; n=20 DRSP-EE) |
2.8
(2.2)
|
3.0
(1.9)
|
| 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 | 1312 | 436 |
| Cycle 1 (n=986 NOMAC-E2; n=375 DRSP-EE) |
5.7
(5.0)
|
6.0
(3.5)
|
| Cycle 2 (n=783 NOMAC-E2; n=293 DRSP-EE) |
5.0
(4.6)
|
6.2
(17.1)
|
| Cycle 3 (n=634 NOMAC-E2; n=241 DRSP-EE) |
4.8
(4.4)
|
6.6
(18.9)
|
| Cycle 4 (n=555 NOMAC-E2; n=220 DRSP-EE) |
4.5
(2.9)
|
6.5
(19.8)
|
| Cycle 5 (n=502 NOMAC-E2; n=216 DRSP-EE) |
4.5
(3.5)
|
6.6
(19.9)
|
| Cycle 6 (n=462 NOMAC-E2; n=198 DRSP-EE) |
4.1
(2.5)
|
6.6
(20.8)
|
| Cycle 7 (n=426 NOMAC-E2; n=183 DRSP-EE) |
4.2
(3.4)
|
6.5
(21.6)
|
| Cycle 8 (n=391 NOMAC-E2; n=173 DRSP-EE) |
4.1
(2.4)
|
6.8
(22.3)
|
| Cycle 9 (n=356 NOMAC-E2; n=165 DRSP-EE) |
3.9
(2.2)
|
6.9
(22.8)
|
| Cycle 10 (n=344 NOMAC-E2; n=162 DRSP-EE) |
4.2
(2.8)
|
6.8
(23.0)
|
| Cycle 11 (n=300 NOMAC-E2; n=154 DRSP-EE) |
3.8
(1.9)
|
6.8
(23.6)
|
| Cycle 12 (n=287 NOMAC-E2; n=142 DRSP-EE) |
3.8
(2.5)
|
6.9
(24.6)
|
| Cycle 13 (n=196 NOMAC-E2; n=126 DRSP-EE) |
2.8
(2.3)
|
4.3
(1.6)
|
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 | 32/1666 (1.9%) | 6/554 (1.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Cardiac disorders | ||||
| Cardiac aneurysm | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Venous angioma of brain | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 0/1666 (0%) | 0 | 1/554 (0.2%) | 1 |
| Gastritis | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis | 2/1666 (0.1%) | 2 | 0/554 (0%) | 0 |
| Cholelithiasis | 5/1666 (0.3%) | 5 | 0/554 (0%) | 0 |
| Infections and infestations | ||||
| Appendicitis | 2/1666 (0.1%) | 2 | 2/554 (0.4%) | 2 |
| Bacterial diarrhoea | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Pneumonia | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Pyelonephritis | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Ankle fracture | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Femur fracture | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Joint dislocation | 0/1666 (0%) | 0 | 1/554 (0.2%) | 1 |
| Post procedural complication | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Post procedural haemorrhage | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Road traffic accident | 2/1666 (0.1%) | 2 | 0/554 (0%) | 0 |
| Spinal cord injury cervical | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Benign breast neoplasm | 0/1666 (0%) | 0 | 1/554 (0.2%) | 1 |
| Breast cancer | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Carcinoid tumor of the appendix | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Degeneration of uterine fibroid | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Nervous system disorders | ||||
| Migraine | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Optic neuritis | 1/1666 (0.1%) | 2 | 0/554 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||
| Premature separation of placenta | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Psychiatric disorders | ||||
| Major depression | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Psychotic disorder | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Endometriosis | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthmatic crisis | 0/1666 (0%) | 0 | 1/554 (0.2%) | 1 |
| Surgical and medical procedures | ||||
| Breast cosmetic surgery | 1/1666 (0.1%) | 1 | 0/554 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| NOMAC-E2 | DRSP-EE | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 720/1666 (43.2%) | 162/554 (29.2%) | ||
| Investigations | ||||
| Weight increased | 210/1666 (12.6%) | 215 | 38/554 (6.9%) | 38 |
| Nervous system disorders | ||||
| Headache | 121/1666 (7.3%) | 162 | 46/554 (8.3%) | 69 |
| Reproductive system and breast disorders | ||||
| Cervical dysplasia | 77/1666 (4.6%) | 78 | 34/554 (6.1%) | 35 |
| Metrorrhagia | 102/1666 (6.1%) | 120 | 17/554 (3.1%) | 18 |
| Withdrawal bleeding irregular | 154/1666 (9.2%) | 293 | 3/554 (0.5%) | 6 |
| Skin and subcutaneous tissue disorders | ||||
| Acne | 327/1666 (19.6%) | 390 | 60/554 (10.8%) | 69 |
Limitations/Caveats
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 |
- P05722
- 292002