Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome (NCT00427700) | Clinical Trial Compass
CompletedPhase 3
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
Brazil82 participantsStarted 2008-08
Plain-language summary
The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity.
Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation.
The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.
Who can participate
Age range
18 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e., oligoovulation defined as \< 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey \>8) or laboratorial (total Testosterone \>=0.81 ng/dL) or polycystic ovary \> 10cm3.
Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol
* Age \>18 years old and \<= 38 years old.
* No endometriosis on laparoscopy
Exclusion Criteria:
* Not willing to participate in the study
* use of IUD or contraceptive pill within 2 months before the study.
* Hyperprolactinemia (\>20ng/mL)
* Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).
* High 17-OH progesterone (\>=4.9ng/mL)
* Endometriosis
* Known allergy to clomiphene or raloxifene
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Ovulation Detected by Ultrasound