Clinical trial · Interventional
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition
Assessment of Sensitivity of the Hypothalamic GnRH Pulse Generator to Estradiol and Progesterone Inhibition in Early Pubertal Girls (JCM026)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The research questions was changed/de-prioritized. Only one subject completed.
Summary
Brief summary (as posted)
Gonadotropin-releasing hormone (GnRH) is a hormone that regulates the ability of the pituitary to secrete two hormones, luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH control the production of female hormones (such as estrogen and progesterone) and the development of eggs by the ovary. Progesterone and estrogen then decrease the number of GnRH pulses produced by the brain (and therefore the number of LH pulses from the pituitary). The ability to decrease GnRH pulses seems to be very important for normal menstrual function in adult women. The purpose of this study is to learn more about how GnRH and LH pulses are controlled during puberty. The information gathered in this study will hopefully allow us to learn more about how menstrual cycles are normally established in girls during puberty.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperandrogenemia | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Estrace (estrogen) | Drug | — | UNRESOLVED |
| Progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Progesterone, estrace
- description
- 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
- interventionNames
- Drug: Progesterone
- Drug: Estrace (estrogen)
Primary outcomes (1)
- measure
- LH Pulse Frequency as a Function of Day 7 Progesterone
- timeFrame
- 7 days following oral estrace and progesterone administration
- description
- number of LH pulses per 11 hours on Day 7 of progesterone
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 8 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available