DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Milton S. Hershey Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Clomiphene Citrate (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Milton S. Hershey Medical Center

Official(s) and/or principal investigator(s):
Carol L Gnatuk, M.D., Principal Investigator, Affiliation: a State University Hershey Medical Center /Mayo Clinic when study was conducted

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.

Clinical Details

Official title: FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: LH Concentration

Secondary outcome: FSH Concentration

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Mayo Clinic, Rochester, Minnesota 55905, United States
Additional Information

Starting date: March 1991
Last updated: December 19, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017