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Sponsors and Collaborators: |
University of Virginia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | University of Virginia |
ClinicalTrials.gov Identifier: | NCT00594217 |
The rapidity with which Progesterone (P) suppresses daytime lutenizing hormone (LH) (and by inference gonadotropin releasing hormone (GnRH)) pulse frequency is unknown. We propose to assess this further using a randomized, cross-over, placebo-controlled study. Ovulatory women pretreated with estradiol (E2) will undergo a 24-hour sampling study in the General Clinical Research Center (GCRC). After 10 hours of sampling, either oral micronized progesterone (100 mg p.o.) suspension or placebo suspension will be administered (according to randomization). During a subsequent menstrual cycle, subjects will undergo another GCRC study identical to the first (including pretreatment with E2) except that oral progesterone will be exchanged for placebo or vice versa in accordance with the crossover design. We will assess the acute effects of progesterone on LH frequency, with secondary endpoints being mean LH, LH pulse amplitude, and mean follicle-stimulating hormone (FSH). We hypothesize that administration of P (at 0600 h) to adult women during the follicular phase will result in a demonstrable suppression of daytime LH (and by inference GnRH) pulse frequency within 12 hours.
Ovulatory women will begin E2 (estradiol) patches on day 4-8 of the cycle. On day 7-11 of the study cycle (i.e., after 3 days of E2 administration), women will undergo a 24-hr sampling study in the General Clinical Research Center. Beginning at 2000 hr, blood for LH (lutenizing hormone), FSH (follicle-stimulating hormone), E2 (estradiol), P (progesterone), and T (testosterone) will be obtained over a 24-hour period. After 10 hours of sampling, either oral micronized P (100 mg p.o.) suspension or placebo suspension will be administered (according to randomization). At the completion of sampling, E2 patches will be discontinued. During a subsequent menstrual cycle, subjects will undergo another GCRC study identical to the first (including pretreatment with E2) except that oral P will be exchanged for placebo or vice versa in accordance with the crossover design.
Hypothesis to be Tested: Administration of P (at 0600 h) to adult women during the follicular phase will result in a demonstrable suppression of daytime LH (and by inference GnRH) pulse frequency within 12 hours. We will also assess the acute effects of P on mean LH, LH pulse amplitude, and mean FSH.
Condition | Intervention |
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PCOS |
Drug: oral micronized P suspension Other: Placebo |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Determining the Rapidity With Which Exogenous P Suppresses Daytime LH (GnRH) Pulse Frequency in Women During the Follicular Phase of the Menstrual Cycle |
Estimated Enrollment: | 33 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
oral micronized P (100 mg p.o.) suspension
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Drug: oral micronized P suspension
oral micronized P (100 mg p.o.) suspension
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2: Placebo Comparator
Placebo
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Other: Placebo
Placebo
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Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher McCartney, MD | 434-243-6911 | cm2hq@virginia.edu |
Contact: Lauren Lockhart | 434-243-6911 | lsa5s@virginia.edu |
United States, Virginia | |
University of Virginia | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Lauren Lockhart 434-243-6911 lsa5s@virginia.edu | |
Contact: Christopher McCartney, MD 434-243-6911 cm2hq@virginia.edu | |
Principal Investigator: Christopher McCartney, MD |
Principal Investigator: | Christopher McCartney, MD | University of Virginia |
Responsible Party: | University of Virginia ( Christopher McCartney, MD ) |
Study ID Numbers: | 13368 |
Study First Received: | January 4, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00594217 |
Health Authority: | United States: Food and Drug Administration |
PCOS |