Trial · NCT00745901
Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
NCT00745901, Phase 4, Completed, Ortho-McNeil Janssen Scientific Affairs, LLC; results first posted 2010-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females. Trials, record NCT00745901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00745901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
- NCT number
- NCT00745901
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 355 participants, actual
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Conditions
- Contraception
- Interventions
- Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
- First posted
- 2008-09-03
- Last updated
- 2019-03-19
- Results first posted
- 2010-05-25
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Days of Unscheduled Blood Loss - Cycle 1 | Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE) | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Primary | Number of Days of Unscheduled Blood Loss - Cycle 2 | Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE) | cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Primary | Number of Days of Unscheduled Blood Loss - Cycle 3 | Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE) | Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Primary | Overall Number of Days of Unscheduled Blood Loss | Cycle 1 to Cycle 3 (Day 8 to Day 80) | cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. |
| Primary | Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes | Cycle 1 to Cycle 3 (Day 8 to Day 80) | Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day. |
| Primary | Number of Days of Scheduled Blood Loss - Cycle 1 | Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE) | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Primary | Number of Days of Scheduled Blood Loss - Cycle 2 | Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE) | cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Primary | Number of Days of Scheduled Blood Loss - Cycle 3 | Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE) | cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Primary | Overall Number of Days of Scheduled Blood Loss | Cycle 1 to Cycle 3 (Day 8 to Day 84) | summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. |
| Primary | Number of Days of Total Blood Loss - Cycle 1 | Cycle 1 (Day 8 to Day 28) | cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Days of Unscheduled Blood Loss - Cycle 1 | Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Days | MEAN |
| SECONDARY | Patient Satisfaction - Overall | Cycle 1 to Cycle 3 | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Participants | NUMBER |
| PRIMARY | Number of Days of Unscheduled Blood Loss - Cycle 2 | Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. | Days | MEAN |
| PRIMARY | Number of Days of Unscheduled Blood Loss - Cycle 3 | Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. | Days | MEAN |
| PRIMARY | Overall Number of Days of Unscheduled Blood Loss | Cycle 1 to Cycle 3 (Day 8 to Day 80) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Days | MEAN |
| PRIMARY | Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes | Cycle 1 to Cycle 3 (Day 8 to Day 80) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Participants | NUMBER |
| PRIMARY | Number of Days of Scheduled Blood Loss - Cycle 1 | Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Days | MEAN |
| PRIMARY | Number of Days of Scheduled Blood Loss - Cycle 2 | Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 2. | Days | MEAN |
| PRIMARY | Number of Days of Scheduled Blood Loss - Cycle 3 | Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. Include patients with at least one day evaluable in cycle 3. | Days | MEAN |
| PRIMARY | Overall Number of Days of Scheduled Blood Loss | Cycle 1 to Cycle 3 (Day 8 to Day 84) | Efficacy Analysis Population: all randomized patients who took study drug and for whom there was post-baseline blood loss data after Day 7. | Days | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Days of Unscheduled Blood Loss - Cycle 1 | NGM/25mcg EE | 1.9 | Standard Deviation 3.14 | Days | |
| Number of Days of Unscheduled Blood Loss - Cycle 1 | DRSP/20mcg EE | 2.0 | Standard Deviation 3.53 | Days | |
| Patient Satisfaction - Overall | NGM/25mcg EE | Number of responses | 159 | Participants | |
| Patient Satisfaction - Overall | DRSP/20mcg EE | Number of responses | 162 | Participants | |
| Patient Satisfaction - Overall | NGM/25mcg EE | 1. Very Satisfied | 99 | Participants | |
| Patient Satisfaction - Overall | DRSP/20mcg EE | 1. Very Satisfied | 115 | Participants | |
| Patient Satisfaction - Overall | NGM/25mcg EE | 2. Somewhat satisfied | 35 | Participants | |
| Patient Satisfaction - Overall | DRSP/20mcg EE | 2. Somewhat satisfied | 32 | Participants | |
| Patient Satisfaction - Overall | NGM/25mcg EE | 3. Neither satisfied or dissatisfied | 12 | Participants | |
| Patient Satisfaction - Overall | DRSP/20mcg EE | 3. Neither satisfied or dissatisfied | 6 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NGM/25mcg EE | 178 | |
| Overall Study | STARTED | DRSP/20mcg EE | 177 | |
| Overall Study | COMPLETED | NGM/25mcg EE | 154 | |
| Overall Study | COMPLETED | DRSP/20mcg EE | 156 | |
| Overall Study | NOT COMPLETED | NGM/25mcg EE | 24 | |
| Overall Study | NOT COMPLETED | DRSP/20mcg EE | 21 |
Source ClinicalTrials.gov
Adverse events122
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 | Acne | Skin and subcutaneous tissue disorders | NGM/25mcg EE | 0 | 167 | |
| other | Acne | Skin and subcutaneous tissue disorders | DRSP/20mcg EE | 3 | 167 | |
| other | Abdominal distension | Gastrointestinal disorders | NGM/25mcg EE | 1 | 167 | |
| other | Abdominal distension | Gastrointestinal disorders | DRSP/20mcg EE | 0 | 167 | |
| other | Anxiety disorder | Psychiatric disorders | NGM/25mcg EE | 0 | 167 | |
| other | Anxiety disorder | Psychiatric disorders | DRSP/20mcg EE | 1 | 167 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | NGM/25mcg EE | 1 | 167 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | DRSP/20mcg EE | 2 | 167 | |
| other | Breast tenderness | Reproductive system and breast disorders | NGM/25mcg EE | 2 | 167 | |
| other | Breast tenderness | Reproductive system and breast disorders | DRSP/20mcg EE | 0 | 167 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NGM/25mcg EE | ||
| Total, all-cause mortality | DRSP/20mcg EE | ||
| Total, other adverse events | NGM/25mcg EE | 34 | 167 |
| Total, other adverse events | DRSP/20mcg EE | 34 | 167 |
| Total, serious adverse events | NGM/25mcg EE | 2 | 167 |
| Total, serious adverse events | DRSP/20mcg EE | 1 | 167 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19935020 | RESULT |
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Breakthrough Bleeding/Spotting Cycle 2 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Unscheduled Bleeding Cycle 3 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Breakthrough Bleeding/Spotting Cycle 3 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Breakthrough Bleeding/Spotting Cycle 1 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Unscheduled Bleeding Cycle 1 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg EE: Number of Participants With Unscheduled Bleeding Cycle 2 | Trial comparisons |
| NGM/25mcg EE vs DRSP/20mcg 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/NCT00745901
GET https://conductscience.org/api/trials/v1/NCT00745901/results?page=2