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Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

NCT ID: NCT01340521

Last Updated: 2012-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1991-03-31

Study Completion Date

1994-03-31

Brief Summary

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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.

Detailed Description

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Empirical use low-dose clomiphene citrate has been advocated by some practitioners to enhance fecundity in women with unexplained infertility. No clinical trials have examined the efficacy of such treatment in the patient population, although certain studies have shown that active ovulation induction can be effective in women with unexplained infertility, and that cycle fecundity is improved for normally cycling women with active ovulation management in a program of artificial insemination. Since clomiphene citrate can have paradoxical effects on fertility through its anti-estrogenic mode of action, the benefit or lack of benefit from treatment with clomiphene citrate in this patient group needs to be evaluated. We aim to establish a dose response of FSH and LH to various low doses of clomiphene citrate in normally cycling women of known fertility, that is women with an intact hypothalamic-pituitary-ovarian-axis. The significance of this information is that it may help to elucidate the mechanism by which low-dose clomiphene citrate may improve fecundity in patients with unexplained infertility as it is currently being used empirically.

Conditions

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Infertility

Keywords

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Pituitary Hormone Response Clomiphene Citrate Follicle Stimulating Hormone Luteinizing Hormone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Clomiphene Citrate

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Women with Infertility issues
* Irregular menstrual cycles
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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The Pennsylvania State University

Principal Investigators

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Carol L Gnatuk, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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214-91

Identifier Type: -

Identifier Source: org_study_id