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

This study has been completed.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01340521
First received: April 18, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Clomiphene Citrate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • LH Concentration [ Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • FSH Concentration [ Time Frame: Outcome measures assessed every month until menses occur for 4 monthly menstrual cycles ] [ Designated as safety issue: No ]
    FSH will be measured from blood samples of approximately 10mL from each subject on cycle day 3, then daily from cycle day 5 through ovulation as determined by urinary testing kit and every third day until menses occur.


Enrollment: 25
Study Start Date: March 1991
Study Completion Date: March 1994
Primary Completion Date: March 1994 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Clomiphene Citrate
    0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.
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

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340521

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Milton S. Hershey Medical Center
Mayo Clinic
Investigators
Principal Investigator: Carol L Gnatuk, M.D. a State University Hershey Medical Center /Mayo Clinic when study was conducted
  More Information

No publications provided

Responsible Party: Carol L. Gnatuk, M.D., The Pennsylvania State University
ClinicalTrials.gov Identifier: NCT01340521     History of Changes
Other Study ID Numbers: 214-91
Study First Received: April 18, 2011
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Pituitary Hormone Response
Clomiphene Citrate
Follicle Stimulating Hormone
Luteinizing Hormone

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on September 18, 2014