Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition (JCM026)
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ClinicalTrials.gov Identifier: NCT01428245 |
Recruitment Status :
Terminated
(The research questions was changed/de-prioritized. Only one subject completed.)
First Posted : September 2, 2011
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperandrogenemia Polycystic Ovary Syndrome | Drug: Progesterone Drug: Estrace (estrogen) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026) |
Actual Study Start Date : | April 22, 2011 |
Actual Primary Completion Date : | May 14, 2013 |
Actual Study Completion Date : | May 14, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Progesterone, estrace
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr to achieve mean plasma concentrations over the range of 2-8 ng/ml for seven days oral estrace, 0.5-1 mg once a day for seven days |
Drug: Progesterone
oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days Drug: Estrace (estrogen) oral estrace, 0.5-1 mg once a day for seven days
Other Name: estradiol |
- LH Pulse Frequency as a Function of Day 7 Progesterone [ Time Frame: 7 days following oral estrace and progesterone administration ]number of LH pulses per 11 hours on Day 7 of progesterone

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Ages Eligible for Study: | 8 Years to 14 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Girls ages 8 to 14
- Tanner 1-3 pubertal stage
- Pre-menarchal
- Normal screening labs
Exclusion Criteria:
- Abnormal screening labs
- Congenital adrenal hyperplasia
- Hyperandrogenism (e.g., hirsutism, elevated free testosterone level)
- Hemoglobin <12 mg/dL or hematocrit < 36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit.)
- Weight < 31 kg
- History of peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
- On hormonal medications (including oral contraceptive pills) or on medications known to affect the reproductive axis within 3 months of the study
- Pregnant or breast feeding
- Participation in a research study within the past 30 days that involved taking a study drug.
- Participation in a research study that involved taking up to or greater than 473 ml's of blood within the past 60 days.
- Cigarette smoking
- History of surgery that required bedrest within the past 30 days
- Family history of hypercoagulability or unexplained thromboembolic disease (not in setting of bedrest, surgery, or malignancy)
- In order to ensure an adequate number of younger girls, no more than 4 enrolled subjects will be Tanner stage 3

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428245
United States, Virginia | |
Center for Research in Reproduction, University of Virginia | |
Charlottesville, Virginia, United States, 22908 |
Principal Investigator: | John C. Marshall, MD, PhD | University of Virginia |
Documents provided by John Marshall, University of Virginia:
Responsible Party: | John Marshall, Director, Center for Research in Reproduction, University of Virginia |
ClinicalTrials.gov Identifier: | NCT01428245 |
Other Study ID Numbers: |
14100 U54HD028934 ( U.S. NIH Grant/Contract ) P50HD028934 ( U.S. NIH Grant/Contract ) |
First Posted: | September 2, 2011 Key Record Dates |
Results First Posted: | December 30, 2020 |
Last Update Posted: | December 30, 2020 |
Last Verified: | December 2020 |
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |
Estradiol Estrogens Progesterone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Progestins |