Trial · NCT00394771
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
NCT00394771, Phase 2, Completed, Duramed Research; results first posted 2013-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale. Trials, record NCT00394771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00394771
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
- NCT number
- NCT00394771
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 567 participants, actual
- Lead sponsor
- Duramed Research
- Conditions
- Breakthrough Bleeding
- Interventions
- DR-1031, Seasonale®, Portia®
- First posted
- 2006-11-01
- Last updated
- 2013-07-26
- Results first posted
- 2013-06-19
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | Day 1-84 | Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection. |
| Primary | Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) | Day 92-176 | Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection. |
| Secondary | Days With Bleeding During Active Cycle 1 (Day 1-84) | Day 1-84 | Bleeding is defined as a flow heavy enough to require sanitary protection. |
| Secondary | Days With Bleeding During Active Cycle 2 (Day 92-176) | Day 92-176 | Bleeding is defined as a flow heavy enough to require sanitary protection. |
| Secondary | Time to First Bleeding Day | Day 1-84 | Time to first bleeding day was defined as the time between the start of intervention until the first day when bleeding was heavy enough to require the use of sanitary protection. Data are not summarized due to limitations in the diary data and an inability to accurately determine a participant's first day of bleeding. |
| Secondary | Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) | Day 1-84 | Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy. Data was not summarized due to limitations in the diary data, and an inability to accurately determine the maximum bleeding severity. See pre-specified analyses for Number of Moderate to Heavy Bleeding Days. |
| Secondary | Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) | Day 85-91 | Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1. |
| Secondary | Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) | Day 177-183 | Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2. |
| Secondary | Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) | Day 1-84 | Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. |
| Secondary | Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) | Day 92-176 | Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | Day 1-84 | Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary. | days | MEDIAN |
| SECONDARY | Days With Bleeding During Active Cycle 1 (Day 1-84) | Day 1-84 | Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary. | days | MEDIAN |
| SECONDARY | Days With Bleeding During Active Cycle 2 (Day 92-176) | Day 92-176 | Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary. | days | MEDIAN |
| SECONDARY | Time to First Bleeding Day | Day 1-84 | ITT population. However this data was not summarized due to limitations in the diary data. | ||
| SECONDARY | Maximum Bleeding Severity During Active Cycle 1 (Day 1-84) | Day 1-84 | ITT population. However data was not summarized due to limitations in the diary data. | ||
| PRIMARY | Days With Bleeding and/or Spotting During Active Cycle 2 (Day 92-176) | Day 92-176 | Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary. | days | MEDIAN |
| SECONDARY | Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 1 (Day 85-91) | Day 85-91 | Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary. | participants | NUMBER |
| SECONDARY | Participants With Bleeding and/or Spotting Days During the 7-day Withdrawal During Cycle 2 (Day 177-183) | Day 177-183 | Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary. | participants | NUMBER |
| SECONDARY | Participants Reporting Hormone-Related Symptoms During Active Cycle 1 (Day 1-84) | Day 1-84 | Intent to treat (ITT) population of participants who completed the relevant pages in the patient diary. | participants | NUMBER |
| SECONDARY | Participants Reporting Hormone-Related Symptoms During Active Cycle 2 (Day 92-176) | Day 92-176 | Intent to treat (ITT) population of participants who were still active in the study and who completed the relevant pages in the patient diary. | participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | Low Dose DR-1031 | 13 | Full Range 0 to 67 | days | |
| Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | Midrange Dose DR-1031 | 13.5 | Full Range 0 to 65 | days | |
| Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | High Dose DR-1031 | 15 | Full Range 0 to 69 | days | |
| Days With Bleeding and/or Spotting During Active Cycle 1 (Day 1-84) | Seasonale | 15 | Full Range 0 to 56 | days | |
| Days With Bleeding During Active Cycle 1 (Day 1-84) | Low Dose DR-1031 | 3.5 | Full Range 0 to 24 | days | |
| Days With Bleeding During Active Cycle 1 (Day 1-84) | Midrange Dose DR-1031 | 2.5 | Full Range 0 to 49 | days | |
| Days With Bleeding During Active Cycle 1 (Day 1-84) | High Dose DR-1031 | 4 | Full Range 0 to 47 | days | |
| Days With Bleeding During Active Cycle 1 (Day 1-84) | Seasonale | 2 | Full Range 0 to 24 | days | |
| Days With Bleeding During Active Cycle 2 (Day 92-176) | Low Dose DR-1031 | 1 | Full Range 0 to 24 | days | |
| Days With Bleeding During Active Cycle 2 (Day 92-176) | Midrange Dose DR-1031 | 2 | Full Range 0 to 49 | days |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose DR-1031 | 140 | |
| Overall Study | STARTED | Midrange Dose DR-1031 | 136 | |
| Overall Study | STARTED | High Dose DR-1031 | 143 | |
| Overall Study | STARTED | Seasonale | 148 | |
| Overall Study | Intent to Treat (ITT) Population | Low Dose DR-1031 | 110 | |
| Overall Study | Intent to Treat (ITT) Population | Midrange Dose DR-1031 | 110 | |
| Overall Study | Intent to Treat (ITT) Population | High Dose DR-1031 | 108 | |
| Overall Study | Intent to Treat (ITT) Population | Seasonale | 120 | |
| Overall Study | COMPLETED | Low Dose DR-1031 | 99 | |
| Overall Study | COMPLETED | Midrange Dose DR-1031 | 102 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events88
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 | Headache | Nervous system disorders | Low Dose DR-1031 | 19 | 140 | |
| other | Headache | Nervous system disorders | Midrange Dose DR-1031 | 19 | 136 | |
| other | Headache | Nervous system disorders | High Dose DR-1031 | 23 | 143 | |
| other | Headache | Nervous system disorders | Seasonale | 19 | 148 | |
| other | Migraine | Nervous system disorders | Low Dose DR-1031 | 2 | 140 | |
| other | Migraine | Nervous system disorders | Midrange Dose DR-1031 | 7 | 136 | |
| other | Migraine | Nervous system disorders | High Dose DR-1031 | 1 | 143 | |
| other | Migraine | Nervous system disorders | Seasonale | 2 | 148 | |
| other | Nasopharyngitis | Infections and infestations | Low Dose DR-1031 | 15 | 140 | |
| other | Nasopharyngitis | Infections and infestations | Midrange Dose DR-1031 | 7 | 136 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose DR-1031 | ||
| Total, all-cause mortality | Midrange Dose DR-1031 | ||
| Total, all-cause mortality | High Dose DR-1031 | ||
| Total, all-cause mortality | Seasonale | ||
| Total, other adverse events | Low Dose DR-1031 | 61 | 140 |
| Total, other adverse events | Midrange Dose DR-1031 | 44 | 136 |
| Total, other adverse events | High Dose DR-1031 | 49 | 143 |
| Total, other adverse events | Seasonale | 53 | 148 |
| Total, serious adverse events | Low Dose DR-1031 | 1 | 140 |
| Total, serious adverse events | Midrange Dose DR-1031 | 2 | 136 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00394771
GET https://conductscience.org/api/trials/v1/NCT00394771/results?page=2