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

NCT00427700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-08-21

Study results available
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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.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

clomiphene citrate

100mg PO on days 5-9 of the menstrual cycle

DRUG

raloxifene

100mg PO on days 5-9 of the menstrual cycle

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Ricardo F Savaris, MD, PhD · Hospital de Clínicas de Porto Alegre

  • Helena Corleta, MD, PhD · Hospital de Clínicas de Porto Alegre

  • Bruce A Lessey, MD, PhD · Greenville Hospital System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00427700 on ClinicalTrials.gov