Trial · NCT01656434
Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
NCT01656434, Phase 3, Terminated, Organon and Co; results first posted 2015-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448). Trials, record NCT01656434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01656434
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
- NCT number
- NCT01656434
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,173 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Contraception
- Interventions
- NOMAC-E2, NETA-EE, Placebo, ethinylestradiol (EE), ferrous fumarate
- First posted
- 2012-08-03
- Last updated
- 2024-06-20
- Results first posted
- 2015-03-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index) | Up to 1 year (13 cycles) | Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure. |
| Secondary | Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Up to 1 year (13 cycles) | Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required \>=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING. |
| Secondary | Percentage of Participants With an Absence of Withdrawal Bleeding | Up to 1 year (13 cycles) | Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period. |
| Secondary | Percentage of Participants Who Experienced At Least One Adverse Event | Up to 54 weeks | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. |
| Secondary | Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | Up to 54 weeks | |
| Secondary | Change From Baseline in Body Weight | Baseline and Week 52 | Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants. |
Source ClinicalTrials.gov
Outcomes6
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 Per 100 Woman Years of Exposure (Pearl Index) | Up to 1 year (13 cycles) | Planned analysis for this primary endpoint was not performed due to early study termination. | ||
| SECONDARY | Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting | Up to 1 year (13 cycles) | Planned analysis for this secondary endpoint was not performed due to early study termination. | ||
| SECONDARY | Percentage of Participants With an Absence of Withdrawal Bleeding | Up to 1 year (13 cycles) | Planned analysis for this secondary endpoint was not performed due to early study termination. | ||
| SECONDARY | Percentage of Participants Who Experienced At Least One Adverse Event | Up to 54 weeks | All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | Up to 54 weeks | All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Body Weight | Baseline and Week 52 | Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint. | kilograms | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced At Least One Adverse Event | NOMAC-E2 | 41.2 | Percentage of Participants | ||
| Percentage of Participants Who Experienced At Least One Adverse Event | NETA-EE | 45.2 | Percentage of Participants | ||
| Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | NOMAC-E2 | 0 | Participants | ||
| Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | NETA-EE | 1 | Participants | ||
| Change From Baseline in Body Weight | NOMAC-E2 | After Cycle 3 (n=2135; n=527) | 0.14 | Standard Error 0.14 | kilograms |
| Change From Baseline in Body Weight | NETA-EE | After Cycle 3 (n=2135; n=527) | 0.41 | Standard Error 0.24 | kilograms |
| Change From Baseline in Body Weight | NOMAC-E2 | After Cycle 6 (n=1809; n=459) | 0.64 | Standard Error 0.18 | kilograms |
| Change From Baseline in Body Weight | NETA-EE | After Cycle 6 (n=1809; n=459) | 0.29 | Standard Error 0.28 | kilograms |
| Change From Baseline in Body Weight | NOMAC-E2 | After Cycle 9 (n=1468; n=391) | 1.21 | Standard Error 0.23 | kilograms |
| Change From Baseline in Body Weight | NETA-EE | After Cycle 9 (n=1468; n=391) | 0.32 | Standard Error 0.35 | kilograms |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NOMAC-E2 | 2,553 | |
| Overall Study | STARTED | NETA-EE | 620 | |
| Overall Study | Treated | NOMAC-E2 | 2,466 | |
| Overall Study | Treated | NETA-EE | 604 | |
| Overall Study | COMPLETED | NOMAC-E2 | 152 | |
| Overall Study | COMPLETED | NETA-EE | 40 | |
| Overall Study | NOT COMPLETED | NOMAC-E2 | 2,401 | |
| Overall Study | NOT COMPLETED | NETA-EE | 580 |
Source ClinicalTrials.gov
Adverse events62
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 |
|---|---|---|---|---|---|---|
| serious | Internal hernia | Gastrointestinal disorders | NOMAC-E2 | 0 | 2,465 | 0 |
| serious | Internal hernia | Gastrointestinal disorders | NETA-EE | 1 | 604 | 1 |
| serious | Irritable bowel syndrome | Gastrointestinal disorders | NOMAC-E2 | 1 | 2,465 | 1 |
| serious | Irritable bowel syndrome | Gastrointestinal disorders | NETA-EE | 0 | 604 | 0 |
| serious | Cholecystitis chronic | Hepatobiliary disorders | NOMAC-E2 | 1 | 2,465 | 1 |
| serious | Cholecystitis chronic | Hepatobiliary disorders | NETA-EE | 0 | 604 | 0 |
| serious | Anaphylactic reaction | Immune system disorders | NOMAC-E2 | 1 | 2,465 | 1 |
| serious | Anaphylactic reaction | Immune system disorders | NETA-EE | 0 | 604 | 0 |
| serious | Bacterial pyelonephritis | Infections and infestations | NOMAC-E2 | 0 | 2,465 | 0 |
| serious | Bacterial pyelonephritis | Infections and infestations | NETA-EE | 1 | 604 | 1 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 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 | NETA-EE | ||
| Total, other adverse events | NOMAC-E2 | 0 | 2,465 |
| Total, other adverse events | NETA-EE | 0 | 604 |
| Total, serious adverse events | NOMAC-E2 | 20 | 2,465 |
| Total, serious adverse events | NETA-EE | 8 | 604 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31069056 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NOMAC-E2 vs NETA-EE: Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event | Trial comparisons |
| NOMAC-E2 vs NETA-EE: serious adverse events | 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/NCT01656434
GET https://conductscience.org/api/trials/v1/NCT01656434/events?page=2