Phase 3
Completed N=82
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
Source: ClinicalTrials.gov NCT00427700 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Ovulation Detected by Ultrasound — 52.5; 40.4 percentage of participants — p=0.3
◆ Published Evidence
Emerging
17citations · ~1 / year
Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome.
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.
Linked Publications
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Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Ovulation Detected by Ultrasound |
52.5; 40.4 | 0.3 |
| SECONDARY Serum Levels of Progesterone |
26.1; 40 | 0.2 |
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT00427700) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.