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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

April 18, 2011
December 19, 2012
March 1991
March 1994   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01340521 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women
FSH and LH Response to Low Dose Clomiphene Citrate in Normally Menstruating Fertile Women

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
Drug: Clomiphene Citrate
0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 1994
March 1994   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01340521
214-91
No
Carol L. Gnatuk, M.D., The Pennsylvania State University
Milton S. Hershey Medical Center
Mayo Clinic
Principal Investigator: Carol L Gnatuk, M.D. a State University Hershey Medical Center /Mayo Clinic when study was conducted
Milton S. Hershey Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP