Polycystic Ovarian Syndrome
Conditions
Keywords
PCOS, Infertility, Anovulation
Brief summary
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
Detailed description
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
Interventions
DRUGRaloxifene
Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
DRUGClomiphene
Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
Sponsors
Bruce Lessey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged 18 to 36 2. BMI \> 19 & \< 40 3. PCOS diagnosis as evidenced by: Oligo- and/or anovulation (\< 6 cycles per year) and one of the following: * Clinical and/or biochemical signs of hyperandrogenism * Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
Exclusion criteria
1. Use of ovulation induction agents within the past 6 months 2. Positive pregnancy test before taking study medications 3. History or current thromboembolic disorder 4. Coronary artery disease such as heart attack or stroke 5. Tobacco use or history within the past 6 months 6. History of pelvic inflammatory disease and tubal factor infertility 7. Congenital adrenal hyperplasia 8. Diabetes Mellitus * Any subject on Metformin must wash out for 30 days prior to screening 9. History of endometriosis 10. Known male factor infertility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation | Cycle day 22-24 | If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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
Population: The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown and data collection is incomplete.
Secondary
Ovulation
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Time frame: Cycle day 22-24
Population: Data collected could not be analyzed as it was never unblended and randomization is unknown.