NCT01340521

Brief Summary

The goal of the study is to quantitatively evaluate pituitary hormone response, follicle stimulating hormone (FSH) and luteinizing hormone (LH), to low doses of clomiphene citrate in normally fertile women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 1991

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1991

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 1994

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1994

Completed
17.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed
Last Updated

December 20, 2012

Status Verified

December 1, 2012

Enrollment Period

3 years

First QC Date

April 18, 2011

Last Update Submit

December 19, 2012

Conditions

Infertility

Keywords

Pituitary Hormone ResponseClomiphene CitrateFollicle Stimulating HormoneLuteinizing Hormone

Outcome Measures

Primary Outcomes (1)

  • LH Concentration

    LH will be measured from blood samples of approximately 10 mL from each subject on cycle day 3 and then daily on cycle day 5 through ovulation as determined by urinary LH testing kit and every 3rd day until menses occur.

    Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

Secondary Outcomes (1)

  • FSH Concentration

    Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles

Interventions

Clomiphene CitrateDRUG

0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal cycling healthy women with known fertility
  • Regular menses every 24 - 35 days
  • to 35 years of age
  • be within 20% of ideal body weight
  • normal TSH, prolactin and mid luteal phase progesterone

You may not qualify if:

  • Women with Infertility issues
  • Irregular menstrual cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Carol L Gnatuk, M.D.

    a State University Hershey Medical Center /Mayo Clinic when study was conducted

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 22, 2011

Study Start

March 1, 1991

Primary Completion

March 1, 1994

Study Completion

March 1, 1994

Last Updated

December 20, 2012

Record last verified: 2012-12

Locations

US(1)