Trial · NCT00461305
Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
NCT00461305, Phase 2, Phase 3, Completed, Bayer; results first posted 2010-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea. Trials, record NCT00461305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00461305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea
- NCT number
- NCT00461305
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 420 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Dysmenorrhea
- Interventions
- DRSP 3 mg/EE 20 µg (13 cycles), DRSP 3 mg/EE 30 µg (6 cycles)
- First posted
- 2007-04-18
- Last updated
- 2013-01-24
- Results first posted
- 2010-10-01
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Intracyclic Bleeding at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Intracyclic bleedings were defined as bleedings while a participant takes active tablets. |
| Secondary | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Secondary | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | Total dysmenorrheal score was defined as sum of 2 sub-scores: severity of dysmenorrhea (none: 0, mild: 1, moderate: 2, severe: 3) and use of analgesics (none: 0, mild: 1, moderate: 2, severe: 3). Note: used with permission of Nobelpharma Co., Ltd. from the phase 3 clinical study protocol of IKH-01 in dysmenorrhea (associated with endometriosis) (Nobelpharma Co., Ltd.). Changed total dysmenorrheal scores: -6 to -1 mean improvement, 1 to 6 mean worsening, 0 means no change. |
| Secondary | Distribution of Total Dysmenorrhea Score at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Secondary | Distribution of Total Dysmenorrhea Score at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Total dysmenorrhea score was defined as sum of 2 sub-scores: severity of dysmenorrhea and use of analgesics. Higher score means it is more severe. 0=None, 6=Severest. |
| Secondary | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Severity of lower abdominal pain during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | Severity of lumbago during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
| Secondary | Distribution of Severity of Headache During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | Severity of headache during menstruation was rated as none (none), mild (can be easily tolerated), moderate (noticeable, but does not interfere with daily activities), or severe (interferes with daily activities). |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Intracyclic Bleeding at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
| SECONDARY | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | From baseline up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
| SECONDARY | Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 13 | From baseline up to Cycle 13 (364 days) with 28 days per cycle | FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) | participants | NUMBER |
| SECONDARY | Distribution of Total Dysmenorrhea Score at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
| SECONDARY | Distribution of Total Dysmenorrhea Score at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) | participants | NUMBER |
| SECONDARY | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
| SECONDARY | Distribution of Severity of Lower Abdominal Pain During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) | participants | NUMBER |
| SECONDARY | Distribution of Severity of Lumbago During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
| SECONDARY | Distribution of Severity of Lumbago During Menstruation at Cycle 13 | Up to Cycle 13 (364 days) with 28 days per cycle | FAS (Participants with data at Cycle 13, note: no participants were treated with the DRSP 3 mg/EE 30 µg combination beyond 6 cycles) | participants | NUMBER |
| SECONDARY | Distribution of Severity of Headache During Menstruation at Cycle 6 | Up to Cycle 6 (168 days) with 28 days per cycle | FAS (Participants with data at Cycle 6) | participants | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group298
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Intracyclic Bleeding at Cycle 6 | DRSP 3 mg/EE 20 µg (6 Cycles) | 40 | participants | ||
| Number of Participants With Intracyclic Bleeding at Cycle 6 | DRSP 3 mg/EE 30 µg (6 Cycles) | 4 | participants | ||
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 20 µg (6 Cycles) | -6 (change in total dysmenorrhea scores) | 5 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 30 µg (6 Cycles) | -6 (change in total dysmenorrhea scores) | 2 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 20 µg (6 Cycles) | -5 (change in total dysmenorrhea scores) | 22 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 30 µg (6 Cycles) | -5 (change in total dysmenorrhea scores) | 3 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 20 µg (6 Cycles) | -4 (change in total dysmenorrhea scores) | 41 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 30 µg (6 Cycles) | -4 (change in total dysmenorrhea scores) | 8 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 20 µg (6 Cycles) | -3 (change in total dysmenorrhea scores) | 70 | participants | |
| Number of Participants With a Change in Total Dysmenorrhea Score From Baseline to Cycle 6 | DRSP 3 mg/EE 30 µg (6 Cycles) | -3 (change in total dysmenorrhea scores) | 13 | participants |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | DRSP 3 mg/EE 20 µg (13 Cycles) | 355 | |
| Treatment | STARTED | DRSP 3 mg/EE 30 µg (6 Cycles) | 65 | |
| Treatment | Subjects Dispensed Drugs | DRSP 3 mg/EE 20 µg (13 Cycles) | 350 | |
| Treatment | Subjects Dispensed Drugs | DRSP 3 mg/EE 30 µg (6 Cycles) | 65 | |
| Treatment | Subjects Received Treatment | DRSP 3 mg/EE 20 µg (13 Cycles) | 349 | |
| Treatment | Subjects Received Treatment | DRSP 3 mg/EE 30 µg (6 Cycles) | 65 | |
| Treatment | COMPLETED | DRSP 3 mg/EE 20 µg (13 Cycles) | 254 | |
| Treatment | COMPLETED | DRSP 3 mg/EE 30 µg (6 Cycles) | 56 | |
| Treatment | NOT COMPLETED | DRSP 3 mg/EE 20 µg (13 Cycles) | 101 | |
| Treatment | NOT COMPLETED | DRSP 3 mg/EE 30 µg (6 Cycles) | 9 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events60
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 | Abdominal pain lower | Gastrointestinal disorders | DRSP 3 mg/EE 20 µg (13 Cycles) | 53 | 355 | 68 |
| other | Abdominal pain lower | Gastrointestinal disorders | DRSP 3 mg/EE 30 µg (6 Cycles) | 5 | 65 | 6 |
| other | Abdominal pain upper | Gastrointestinal disorders | DRSP 3 mg/EE 20 µg (13 Cycles) | 13 | 355 | 17 |
| other | Abdominal pain upper | Gastrointestinal disorders | DRSP 3 mg/EE 30 µg (6 Cycles) | 5 | 65 | 5 |
| other | Back pain | Musculoskeletal and connective tissue disorders | DRSP 3 mg/EE 20 µg (13 Cycles) | 25 | 355 | 34 |
| other | Back pain | Musculoskeletal and connective tissue disorders | DRSP 3 mg/EE 30 µg (6 Cycles) | 2 | 65 | 2 |
| other | Blood triglycerides increased | Investigations | DRSP 3 mg/EE 20 µg (13 Cycles) | 29 | 355 | 33 |
| other | Blood triglycerides increased | Investigations | DRSP 3 mg/EE 30 µg (6 Cycles) | 2 | 65 | 3 |
| other | Constipation | Gastrointestinal disorders | DRSP 3 mg/EE 20 µg (13 Cycles) | 19 | 355 | 20 |
| other | Constipation | Gastrointestinal disorders | DRSP 3 mg/EE 30 µg (6 Cycles) | 1 | 65 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DRSP 3 mg/EE 20 µg (13 Cycles) | ||
| Total, all-cause mortality | DRSP 3 mg/EE 30 µg (6 Cycles) | ||
| Total, other adverse events | DRSP 3 mg/EE 20 µg (13 Cycles) | 335 | 355 |
| Total, other adverse events | DRSP 3 mg/EE 30 µg (6 Cycles) | 63 | 65 |
| Total, serious adverse events | DRSP 3 mg/EE 20 µg (13 Cycles) | 5 | 355 |
| Total, serious adverse events | DRSP 3 mg/EE 30 µg (6 Cycles) | 0 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37523477 | 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 |
|---|---|
| DRSP 3 mg/EE 20 µg (6 Cycles) vs DRSP 3 mg/EE 30 µg (6 Cycles): Number of Participants With Intracyclic Bleeding at Cycle 6 | Trial comparisons |
| DRSP 3 mg/EE 20 µg (13 Cycles) vs DRSP 3 mg/EE 30 µg (6 Cycles): 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/NCT00461305
GET https://conductscience.org/api/trials/v1/NCT00461305/registered?page=2