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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Greenville Hospital Center of Women's Medicine
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00427700
First received: January 26, 2007
Last updated: July 7, 2010
Last verified: July 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Ultrasound sign of ovulation [ Time Frame: cycle day 14-20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endometrial biopsy compatible with the +/- 3days of the cycle [ Time Frame: 8-10 days post-ovulation ] [ Designated as safety issue: No ]
  • Serum levels of Progesterone [ Time Frame: 8-10 days after ovulation ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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: 2
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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427700

Contacts
Contact: Ricardo F Savaris, MD, PhD 55 51 91122184 rsavaris@hcpa.ufrgs.br
Contact: Ricardo F Savaris, MD, PhD 51 33311061 rsavaris@hcpa.ufrgs.br

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Contact: Ricardo F Savaris, MD, PhD     55 51 21018405     rsavaris@hcpa.ufrgs.br    
Contact: Eduardo P Passos, MD, PhD     55 51 99810169     epp@via-rs.net    
Principal Investigator: Ricardo F Savaris, MD, PhD            
Sub-Investigator: Eduardo P Passos, MD, PhD            
Sub-Investigator: Helena Corleta, MD, PhD            
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Greenville Hospital Center of Women's Medicine
Investigators
Principal Investigator: Ricardo F Savaris, MD, PhD Hospital de Clínicas de Porto Alegre
Study Chair: Eduardo P Passos, 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ricardo Francalacci Savaris, HCPA-UFRGS
ClinicalTrials.gov Identifier: NCT00427700     History of Changes
Other Study ID Numbers: RACLO
Study First Received: January 26, 2007
Last Updated: July 7, 2010
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Ovarian Cysts
Polycystic Ovary Syndrome
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Raloxifene
Anticoagulants
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013