Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Raloxifene Hydrochloride; Zuclomiphene

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 < 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