Trial · NCT00160199
Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
NCT00160199, Phase 4, Completed, Solvay Pharmaceuticals; results first posted 2010-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion. Trials, record NCT00160199. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00160199
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
- NCT number
- NCT00160199
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 240 participants, actual
- Lead sponsor
- Solvay Pharmaceuticals
- Conditions
- Secondary Amenorrhea
- Interventions
- PROMETRIUM® 300 mg, PROMETRIUM® 400 mg
- First posted
- 2005-09-12
- Last updated
- 2010-07-07
- Results first posted
- 2010-06-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Secretory Conversion of the Endometrium | End of the study (Days 85) | Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria. |
| Primary | Number of Subjects With Withdrawal Bleeding | After first and second cycle (cycle=28 days) | This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle. |
| Secondary | Maximum Intensity of Withdrawal Bleeding After Any Cycle | Duration of withdrawal bleed | The intensity of withdrawal bleeding was classified by: None, Spotting, Light, Moderate, Heavy |
| Secondary | The Duration of Withdrawal Bleeding After the First Treatment Cycle | End of the first cycle of treatment (cycle=28 days) | The numbers of days the subjects actually bled after the end of the first treatment cycle. |
| Secondary | The Duration of Withdrawal Bleeding After Second Treatment Cycle | End of the second cycle of treatment (cycle=28 days) | The numbers of days the subjects actually bled after the end of the second treatment cycle |
| Secondary | Time to Withdrawal Bleeding After First Treatment Cycle | End of the first cycle of treatment (cycle=28 days) | The number of days between the first cycle of treatment and the withdrawal bleeding. |
| Secondary | Time to Withdrawal Bleeding After Second Treatment Cycle | End of the second cycle of treatment (cycle=28 days) | The number of days between the second cycle of treatment and the withdrawal bleeding |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Secretory Conversion of the Endometrium | End of the study (Days 85) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | participants | NUMBER |
| PRIMARY | Number of Subjects With Withdrawal Bleeding | After first and second cycle (cycle=28 days) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | participants | NUMBER |
| SECONDARY | Maximum Intensity of Withdrawal Bleeding After Any Cycle | Duration of withdrawal bleed | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | participants | NUMBER |
| SECONDARY | The Duration of Withdrawal Bleeding After the First Treatment Cycle | End of the first cycle of treatment (cycle=28 days) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Days | MEAN |
| SECONDARY | The Duration of Withdrawal Bleeding After Second Treatment Cycle | End of the second cycle of treatment (cycle=28 days) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Days | MEAN |
| SECONDARY | Time to Withdrawal Bleeding After First Treatment Cycle | End of the first cycle of treatment (cycle=28 days) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Days | MEAN |
| SECONDARY | Time to Withdrawal Bleeding After Second Treatment Cycle | End of the second cycle of treatment (cycle=28 days) | The analysis was done on the Full Analysis Sample defined as subjects who received at least one dose of treatment and with at least one post-baseline evaluable efficacy assessment. Only summary statistics were generated. | Days | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Secretory Conversion of the Endometrium | Prometrium 300 mg/Day | Secretory | 23 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 400 mg/Day | Secretory | 28 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 300 mg/Day | Non-Secretory | 70 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 400 mg/Day | Non-Secretory | 53 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 300 mg/Day | Unable to determine | 7 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 400 mg/Day | Unable to determine | 9 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 300 mg/Day | Unknown | 4 | participants | |
| Secretory Conversion of the Endometrium | Prometrium 400 mg/Day | Unknown | 2 | participants | |
| Number of Subjects With Withdrawal Bleeding | Prometrium 300 mg/Day | 93 | participants | ||
| Number of Subjects With Withdrawal Bleeding | Prometrium 400 mg/Day | 90 | participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prometrium 300 mg/Day | 122 | |
| Overall Study | STARTED | Prometrium 400 mg/Day | 118 | |
| Overall Study | COMPLETED | Prometrium 300 mg/Day | 98 | |
| Overall Study | COMPLETED | Prometrium 400 mg/Day | 81 | |
| Overall Study | NOT COMPLETED | Prometrium 300 mg/Day | 24 | |
| Overall Study | NOT COMPLETED | Prometrium 400 mg/Day | 37 |
Source ClinicalTrials.gov
Adverse events28
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 | Acnes | Skin and subcutaneous tissue disorders | Prometrium 300 mg/Day | 8 | 113 | |
| other | Acnes | Skin and subcutaneous tissue disorders | Prometrium 400 mg/Day | 7 | 107 | |
| other | Asthenic conditions | General disorders | Prometrium 300 mg/Day | 11 | 113 | |
| other | Asthenic conditions | General disorders | Prometrium 400 mg/Day | 7 | 107 | |
| other | Breast signs and symptoms | Reproductive system and breast disorders | Prometrium 300 mg/Day | 8 | 113 | |
| other | Breast signs and symptoms | Reproductive system and breast disorders | Prometrium 400 mg/Day | 5 | 107 | |
| other | Flatulence Bloating and distension | Gastrointestinal disorders | Prometrium 300 mg/Day | 6 | 113 | |
| other | Flatulence Bloating and distension | Gastrointestinal disorders | Prometrium 400 mg/Day | 5 | 107 | |
| other | Fungal infection NEC | Infections and infestations | Prometrium 300 mg/Day | 9 | 113 | |
| other | Fungal infection NEC | Infections and infestations | Prometrium 400 mg/Day | 6 | 107 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prometrium 300 mg/Day | ||
| Total, all-cause mortality | Prometrium 400 mg/Day | ||
| Total, other adverse events | Prometrium 300 mg/Day | 72 | 113 |
| Total, other adverse events | Prometrium 400 mg/Day | 70 | 107 |
| Total, serious adverse events | Prometrium 300 mg/Day | 2 | 113 |
| Total, serious adverse events | Prometrium 400 mg/Day | 1 | 107 |
Source ClinicalTrials.gov
Papers0
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prometrium 300 mg/Day vs Prometrium 400 mg/Day: Number of Subjects With Withdrawal Bleeding | Trial comparisons |
| Prometrium 300 mg/Day vs Prometrium 400 mg/Day: 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/NCT00160199
GET https://conductscience.org/api/trials/v1/NCT00160199/results?page=2