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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:
ClinicalTrials.gov Identifier:
NCT01340521
First Posted: April 22, 2011
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mayo Clinic
Information provided by:
Milton S. Hershey Medical Center
April 18, 2011
April 22, 2011
December 20, 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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: Female
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01340521
214-91
No
Not Provided
Not Provided
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