NCT00427700

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

October 6, 2016

Completed
Last Updated

August 21, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

January 26, 2007

Results QC Date

November 21, 2014

Last Update Submit

July 25, 2024

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndromeclomiphene citrateRaloxifene

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Ovulation Detected by Ultrasound

    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.

    cycle day 14-20

Secondary Outcomes (1)

  • Serum Levels of Progesterone

    8-10 days after ovulation

Study Arms (2)

Clomiphene

ACTIVE COMPARATOR

Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle

Drug: clomiphene citrate

Raloxifene

EXPERIMENTAL

Use of 100mg of raloxifene during days 5-9 of the menstrual cycle

Drug: raloxifene

Interventions

clomiphene citrateDRUG

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

Also known as: Clomid
Clomiphene
raloxifeneDRUG

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

Also known as: Evista
Raloxifene

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (13)

  • 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. doi: 10.1056/NEJM199712043372301.

    PMID: 9385122BACKGROUND

  • 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. doi: 10.1210/jcem.83.1.4448.

    PMID: 9435408BACKGROUND

  • Grimes DA. The "CONSORT" guidelines for randomized controlled trials in Obstetrics & Gynecology. Obstet Gynecol. 2002 Oct;100(4):631-2. doi: 10.1016/s0029-7844(02)02233-0. No abstract available.

    PMID: 12383524BACKGROUND

  • 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. doi: 10.1001/jama.285.15.1987.

    PMID: 11308435BACKGROUND

  • 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. doi: 10.1210/jc.2005-2153. Epub 2006 Jan 17.

    PMID: 16418211BACKGROUND

  • 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. doi: 10.1111/j.1600-0897.1996.tb00031.x.

    PMID: 8962647BACKGROUND

  • 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.

    PMID: 8062944BACKGROUND

  • 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. doi: 10.1016/j.ijgo.2005.10.015. Epub 2006 Mar 10.

    PMID: 16530767BACKGROUND

  • 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. doi: 10.1016/j.fertnstert.2005.09.045. Epub 2006 Mar 9.

    PMID: 16580393BACKGROUND

  • 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.

    PMID: 7851583BACKGROUND

  • 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. doi: 10.1016/j.fertnstert.2005.06.039.

    PMID: 16412752BACKGROUND

  • 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. doi: 10.1136/bmj.319.7211.670.

    PMID: 10480822BACKGROUND

  • de Paula Guedes Neto E, Savaris RF, von Eye Corleta H, de Moraes GS, do Amaral Cristovam R, Lessey BA. Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome. Fertil Steril. 2011 Sep;96(3):769-73. doi: 10.1016/j.fertnstert.2011.06.067. Epub 2011 Jul 22.

    PMID: 21782166DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

ClomipheneRaloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTamoxifen

Results Point of Contact

Title
Dr. Ricardo Francalacci Savaris
Organization
Hospital de Clínicas de Porto Alege
rsavaris@hcpa.edu.br
51 33598405

Study Officials

  • Ricardo F Savaris, MD, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Helena Corleta, MD, PhD

    Hospital de Clínicas de Porto Alegre

    STUDY CHAIR

  • Bruce A Lessey, MD, PhD

    Greenville Hospital System

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 29, 2007

Study Start

August 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

August 21, 2024

Results First Posted

October 6, 2016

Record last verified: 2024-07

Locations

BR(1)