An interventional study of Raloxifene and Clomiphene in Polycystic Ovarian Syndrome, sponsored by Bruce Lessey. Terminated at 1 site in United States. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2018-09-20.
Sponsored by Bruce Lessey · Not applicable, Interventional, and Treatment
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Bruce Lessey as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Oligo- and/or anovulation (\< 6 cycles per year) and one of the following:
Exclusion Criteria:
Diabetes Mellitus
3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
Drug: Raloxifene
3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
Drug: Clomiphene
Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
Also known as: Provera
Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
Also known as: Provera
Pregnancy
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
Time frame: 4 months
Ovulation
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Time frame: Cycle day 22-24
| Milestone | Raloxifene | Clomiphene |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
No measurements were reported for this outcome.
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Study Participants | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | All Study Participants |
|---|---|
| headacheGeneral disorders | 1/3 |
| head coldInfections and infestations | 1/3 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 3 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 3 |
This study is terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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