Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome - Full Text View

Sponsor:	Hospital de Clinicas de Porto Alegre
Collaborator:	Greenville Hospital Center of Women's Medicine
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00427700

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Resource links provided by NLM:

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Raloxifene hydrochloride Raloxifene Citric acid Clomiphene Sodium Citrate trans-Clomifene citrate

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
1: Active Comparator 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 mnestrual cycle
2: Experimental Use of 100mg of raloxifene during days 5-9 of the menstrual cycle	Drug: raloxifene 100mg PO on days 5-9 of the mnestrual cycle

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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: Eduardo P Passos, MD, PhD

55 51 99810169

epp@via-rs.net

Locations

Brazil, Rio Grande do Sul
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:

Delmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, Draper M, Christiansen C. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997 Dec 4;337(23):1641-7.

Baker VL, Draper M, Paul S, Allerheiligen S, Glant M, Shifren J, Jaffe RB. Reproductive endocrine and endometrial effects of raloxifene hydrochloride, a selective estrogen receptor modulator, in women with regular menstrual cycles. J Clin Endocrinol Metab. 1998 Jan;83(1):6-13.

Grimes DA. The "CONSORT" guidelines for randomized controlled trials in Obstetrics & Gynecology. Obstet Gynecol. 2002 Oct;100(4):631-2. No abstract available.

Moher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001 Apr 18;285(15):1987-91. Review.

Azziz R. Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: the Rotterdam criteria are premature. J Clin Endocrinol Metab. 2006 Mar;91(3):781-5. Epub 2006 Jan 17.

Lessey BA, Ilesanmi AO, Lessey MA, Riben M, Harris JE, Chwalisz K. Luminal and glandular endometrial epithelium express integrins differentially throughout the menstrual cycle: implications for implantation, contraception, and infertility. Am J Reprod Immunol. 1996 Mar;35(3):195-204.

Lessey BA, Castelbaum AJ, Buck CA, Lei Y, Yowell CW, Sun J. Further characterization of endometrial integrins during the menstrual cycle and in pregnancy. Fertil Steril. 1994 Sep;62(3):497-506.

Dehbashi S, Vafaei H, Parsanezhad MD, Alborzi S. Time of initiation of clomiphene citrate and pregnancy rate in polycystic ovarian syndrome. Int J Gynaecol Obstet. 2006 Apr;93(1):44-8. Epub 2006 Mar 10.

Bayar U, Tanriverdi HA, Barut A, Ayoglu F, Ozcan O, Kaya E. Letrozole vs. clomiphene citrate in patients with ovulatory infertility. Fertil Steril. 2006 Apr;85(4):1045-8. Epub 2006 Mar 9.

Lessey BA, Castelbaum AJ, Sawin SW, Sun J. Integrins as markers of uterine receptivity in women with primary unexplained infertility. Fertil Steril. 1995 Mar;63(3):535-42.

Savaris RF, Pedrini JL, Flores R, Fabris G, Zettler CG. Expression of alpha 1 and beta 3 integrins subunits in the endometrium of patients with tubal phimosis or hydrosalpinx. Fertil Steril. 2006 Jan;85(1):188-92.

Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. Review.

Responsible Party:	HCPA-UFRGS ( Ricardo Francalacci Savaris )
Study ID Numbers:	RACLO
Study First Received:	January 26, 2007
Last Updated:	December 26, 2008
ClinicalTrials.gov Identifier:	NCT00427700 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hematologic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Bone Density Conservation Agents
Reproductive Control Agents
Ovarian Diseases
Selective Estrogen Receptor Modulators
Genital Diseases, Female
Estrogen Receptor Modulators
Raloxifene
Pathologic Processes

Syndrome
Therapeutic Uses
Estrogen Antagonists
Disease
Anticoagulants
Citric Acid
Endocrine System Diseases
Cysts
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Fertility Agents, Female
Fertility Agents
Polycystic Ovary Syndrome
Chelating Agents

ClinicalTrials.gov processed this record on November 27, 2009