NCT01607320

Brief Summary

This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 15, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 1, 2015

Completed
Last Updated

September 20, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

February 15, 2012

Results QC Date

April 14, 2015

Last Update Submit

August 21, 2018

Conditions

Polycystic Ovarian Syndrome

Keywords

PCOSInfertilityAnovulation

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.

    4 months

Secondary Outcomes (1)

  • Ovulation

    Cycle day 22-24

Study Arms (2)

Raloxifene

EXPERIMENTAL

3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7

Drug: Raloxifene

Clomiphene

ACTIVE COMPARATOR

3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7

Drug: Clomiphene

Interventions

RaloxifeneDRUG

Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal

Also known as: Provera
Raloxifene
ClomipheneDRUG

Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal

Also known as: Provera
Clomiphene

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18 to 36
  • BMI \> 19 \& \< 40
  • PCOS diagnosis as evidenced by:
  • Oligo- and/or anovulation (\< 6 cycles per year) and one of the following:
  • Clinical and/or biochemical signs of hyperandrogenism

You may not qualify if:

  • Use of ovulation induction agents within the past 6 months
  • Positive pregnancy test before taking study medications
  • History or current thromboembolic disorder
  • Coronary artery disease such as heart attack or stroke
  • Tobacco use or history within the past 6 months
  • History of pelvic inflammatory disease and tubal factor infertility
  • Congenital adrenal hyperplasia
  • Diabetes Mellitus
  • Any subject on Metformin must "wash out" for 30 days prior to screening
  • History of endometriosis
  • Known male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInfertilityAnovulation

Interventions

Raloxifene HydrochlorideMedroxyprogesterone AcetateClomiphene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TamoxifenStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Bruce Lessey
Organization
Greenville Health System
blessey@ghs.org
864-455-1600

Study Officials

  • Bruce A. Lessey, MD, PhD

    Greenville Hospital System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD. and Professor of Clinical Obstetrics & Gynecology, Dept of OB/GYN

Study Record Dates

First Submitted

February 15, 2012

First Posted

May 30, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 20, 2018

Results First Posted

June 1, 2015

Record last verified: 2018-08

Locations

US(1)