Trial · NCT00511199
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
NCT00511199, Phase 3, Completed, Organon and Co; results first posted 2011-08-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724). Trials, record NCT00511199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00511199
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
- NCT number
- NCT00511199
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,152 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- NOMAC-E2, DRSP-EE
- First posted
- 2007-08-03
- Last updated
- 2022-02-09
- Results first posted
- 2011-08-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 1 year (13 cycles) | 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). | Pregnancies per 100 woman years | NUMBER |
| PRIMARY | Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | 1 year (13 cycles) | 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). | Pregnancies per 100 woman years | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Every 28-day cycle for 13 cycles (one year total) | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Absence of Withdrawal Bleeding | Every 28-day cycle for 13 cycles (one year total) | 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. | participants | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Breakthrough Bleeding | Every 28-day cycle for 13 cycles (one year total) | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) | Every 28-day cycle for 13 cycles (one year total) | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Early Withdrawal Bleeding | Every 28-day cycle for 13 cycles (one year total) | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With an Occurrence of Continued Withdrawal Bleeding | Every 28-day cycle for 12 cycles | 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. | Participants | NUMBER |
| SECONDARY | Average Number of Breakthrough Bleeding/Spotting Days | Every 28-day cycle for 13 cycles (one year total) | 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. | days | MEAN |
| SECONDARY | Average Number of Withdrawal Bleeding/Spotting Days | Every 28-day cycle for 13 cycles (one year total) | 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. | days | MEAN |
Source ClinicalTrials.gov
Results by group218
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | NOMAC-E2 | Overall group | 0.467 | 95% Confidence Interval 0.1271 to 1.1948 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | DRSP-EE | Overall group | 1.017 | 95% Confidence Interval 0.2097 to 2.971 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | NOMAC-E2 | =<35 years old (n= 1193; n=402) | 0.571 | 95% Confidence Interval 0.1555 to 1.4614 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | DRSP-EE | =<35 years old (n= 1193; n=402) | 1.261 | 95% Confidence Interval 0.2601 to 3.6858 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | NOMAC-E2 | >35 years old (n= 249; n=84) | 0.000 | 95% Confidence Interval 0 to 2.3594 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | DRSP-EE | >35 years old (n= 249; n=84) | 0.000 | 95% Confidence Interval 0 to 6.4466 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | NOMAC-E2 | Overall group | 0.817 | 95% Confidence Interval 0.3283 to 1.6826 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | DRSP-EE | Overall group | 1.356 | 95% Confidence Interval 0.3693 to 3.4707 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | NOMAC-E2 | =<35 years old (n=1193; n=402) | 0.999 | 95% Confidence Interval 0.4016 to 2.058 | Pregnancies per 100 woman years |
| Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) | DRSP-EE | =<35 years old (n=1193; n=402) | 1.682 | 95% Confidence Interval 0.4582 to 4.3056 | Pregnancies per 100 woman years |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NOMAC-E2 | 1,591 | |
| Overall Study | STARTED | DRSP-EE | 535 | |
| Overall Study | COMPLETED | NOMAC-E2 | 1,142 | |
| Overall Study | COMPLETED | DRSP-EE | 410 | |
| Overall Study | NOT COMPLETED | NOMAC-E2 | 449 | |
| Overall Study | NOT COMPLETED | DRSP-EE | 125 |
Source ClinicalTrials.gov
Adverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | NOMAC-E2 | 55 | 1,591 | 61 |
| other | Influenza | Infections and infestations | DRSP-EE | 30 | 535 | 36 |
| other | Nasopharyngitis | Infections and infestations | NOMAC-E2 | 144 | 1,591 | 190 |
| other | Nasopharyngitis | Infections and infestations | DRSP-EE | 53 | 535 | 66 |
| other | Vaginal candidiasis | Infections and infestations | NOMAC-E2 | 127 | 1,591 | 143 |
| other | Vaginal candidiasis | Infections and infestations | DRSP-EE | 45 | 535 | 53 |
| other | Weight increased | Investigations | NOMAC-E2 | 158 | 1,591 | 162 |
| other | Weight increased | Investigations | DRSP-EE | 37 | 535 | 38 |
| other | Headache | Nervous system disorders | NOMAC-E2 | 217 | 1,591 | 405 |
| other | Headache | Nervous system disorders | DRSP-EE | 72 | 535 | 123 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NOMAC-E2 | ||
| Total, all-cause mortality | DRSP-EE | ||
| Total, other adverse events | NOMAC-E2 | 849 | 1,591 |
| Total, other adverse events | DRSP-EE | 242 | 535 |
| Total, serious adverse events | NOMAC-E2 | 38 | 1,591 |
| Total, serious adverse events | DRSP-EE | 13 | 535 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NOMAC-E2 vs DRSP-EE: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00511199
GET https://conductscience.org/api/trials/v1/NCT00511199/results?page=2