At a glance
ClinicalIndex Comparison Record- ✓Female aged 18-50 years
- ✓Not pregnant
- ✓Good medical health
- ✓Medication free (except as specified)
- ✕Current Axis I psychiatric diagnosis (except women with past major depressive episode who are studied separately)
- ✕History of endometriosis
- ✕Undiagnosed pelvic lesions, particularly ovarian enlargement
- ✕Abnormal liver function tests or hepatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement
In Brief
A Phase 2 clinical trial evaluating Leuprolide Acetate 3.75, Estradiol, and 3 other interventions for Healthy Volunteers. Completed, enrolled 100 participants across 1 site.
Detailed Summary
This study evaluates the effects of estrogen and progesterone on mood, the stress response, and brain function in healthy women. The purpose of this study is to evaluate how low levels of estrogen and progesterone (that occur during treatment with leuprolide acetate) compare to menstrual cycle levels of estrogen and progesterone (given during individual months of hormone add-back) on a variety of physiologic measures (brain imaging, stress testing, etc.) in healthy volunteer women without PMS. This study will investigate effects of reproductive hormones by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. Tests (such as brain imaging or stress testing, etc.) will be performed during the different hormonal conditions (low estrogen and progesterone, progesterone add-back, estrogen add-back). The results of these studies will be compared between women without PMS and women with PMS (see also protocol 90-M-0088). At study entry, participants will undergo a physical examination. Blood, urine, and pregnancy tests will be performed. Cognitive functioning and stress response will be evaluated during the study along with brain imaging and genetic studies.
Study Details
Timeline
Interventions
Eight to 12 weeks of GnRH agonist, Leuprolide Acetate 3.75 mg given intramuscularly monthly
Transdermal Estradiol, 100mcg/day by skin patch
Progesterone suppository, 200mg vaginally twice/day
Placebo suppository twice daily
Placebo by skin patch