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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00427700
First Posted: January 29, 2007
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome Drug: clomiphene citrate Drug: raloxifene Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Percentage of Participants With Ovulation Detected by Ultrasound [ Time Frame: cycle day 14-20 ]
    Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.


Secondary Outcome Measures:
  • Serum Levels of Progesterone [ Time Frame: 8-10 days after ovulation ]
    The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.


Enrollment: 82
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clomiphene
Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
Drug: clomiphene citrate
100mg PO on days 5-9 of the menstrual cycle
Other Name: Clomid
Experimental: Raloxifene
Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Drug: raloxifene
100mg PO on days 5-9 of the menstrual cycle
Other Name: Evista

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427700


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Ricardo F Savaris, MD, PhD Hospital de Clínicas de Porto Alegre
Study Chair: Helena Corleta, MD, PhD Hospital de Clínicas de Porto Alegre
Study Director: Bruce A Lessey, MD, PhD Greenville Hospital System
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00427700     History of Changes
Other Study ID Numbers: RACLO
First Submitted: January 26, 2007
First Posted: January 29, 2007
Results First Submitted: November 21, 2014
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
Polycystic Ovary Syndrome
clomiphene citrate
Raloxifene

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Raloxifene Hydrochloride
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators