Trial · NCT00427700
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
NCT00427700, Phase 3, Completed, Hospital de Clinicas de Porto Alegre; results first posted 2016-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome. Trials, record NCT00427700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00427700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
- NCT number
- NCT00427700
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 82 participants, actual
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Conditions
- Polycystic Ovary Syndrome
- Interventions
- clomiphene citrate, raloxifene
- First posted
- 2007-01-29
- Last updated
- 2024-08-21
- Results first posted
- 2016-10-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Ovulation Detected by Ultrasound | cycle day 14-20 | Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure. |
| Secondary | Serum Levels of Progesterone | 8-10 days after ovulation | The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Ovulation Detected by Ultrasound | cycle day 14-20 | intention to treat. | percentage of participants | NUMBER |
| SECONDARY | Serum Levels of Progesterone | 8-10 days after ovulation | Intention to treat.Cases that were lost to follow-up observation, dropped out of the study, failed to collect progesterone on days 22 to 24, and lacked menses after medroxyprogesterone acetate treatment were considered as failures according to the intention-to-treat analysis. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Ovulation Detected by Ultrasound | Clomiphene | 52.5 | 95% Confidence Interval 36.1 to 68.5 | percentage of participants | |
| Percentage of Participants With Ovulation Detected by Ultrasound | Raloxifene | 40.4 | 95% Confidence Interval 25.6 to 56.6 | percentage of participants | |
| Serum Levels of Progesterone | Clomiphene | 26.1 | 95% Confidence Interval 13.8 to 42 | ng/mL | |
| Serum Levels of Progesterone | Raloxiphene | 40 | 95% Confidence Interval 24.8 to 56.6 | ng/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clomiphene | 40 | |
| Overall Study | STARTED | Raloxiphene | 42 | |
| Overall Study | COMPLETED | Clomiphene | 37 | |
| Overall Study | COMPLETED | Raloxiphene | 31 | |
| Overall Study | NOT COMPLETED | Clomiphene | 3 | |
| Overall Study | NOT COMPLETED | Raloxiphene | 11 |
Source ClinicalTrials.gov
Adverse events8
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 | nausea | Gastrointestinal disorders | Clomiphene Citrate | 1 | 40 | 1 |
| other | nausea | Gastrointestinal disorders | Raloxifene | 2 | 42 | 2 |
| other | headache | Nervous system disorders | Clomiphene Citrate | 1 | 40 | 1 |
| other | headache | Nervous system disorders | Raloxifene | 1 | 42 | 1 |
| other | abdominal bloating | Gastrointestinal disorders | Clomiphene Citrate | 1 | 40 | 1 |
| other | abdominal bloating | Gastrointestinal disorders | Raloxifene | 0 | 42 | 0 |
| other | pelvic pain | Reproductive system and breast disorders | Clomiphene Citrate | 0 | 40 | 0 |
| other | pelvic pain | Reproductive system and breast disorders | Raloxifene | 1 | 42 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clomiphene Citrate | ||
| Total, all-cause mortality | Raloxifene | ||
| Total, other adverse events | Clomiphene Citrate | 1 | 40 |
| Total, other adverse events | Raloxifene | 2 | 42 |
| Total, serious adverse events | Clomiphene Citrate | 0 | 40 |
| Total, serious adverse events | Raloxifene | 0 | 42 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Clomiphene Citrate vs Raloxifene: serious adverse events |
Source 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/NCT00427700
GET https://conductscience.org/api/trials/v1/NCT00427700/registered