At a glance
ClinicalIndex Comparison Record- ✓History within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity with sudden onset and offset
- ✓Age 18–50 years
- ✓Not pregnant and in good medical health
- ✓Medication free
- ✕Current Axis I psychiatric diagnosis
- ✕History consistent with endometriosis
- ✕Diagnosis of ill-defined or obscure pelvic lesions, particularly undiagnosed ovarian enlargement
- ✕Hepatic disease manifested by abnormal liver function tests
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Treatment of Menstrually-Related Mood Disorders With the Gonadotropin Releasing Hormone (GnRH) Agonist, Depot Leuprolide Acetate (Lupron)
In Brief
A Phase 1 clinical trial evaluating Leuprolide, Estradiol Patches, and 4 other interventions for Premenstrual Syndrome and Menstruation Disturbances. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This study examines the effects of estrogen and progesterone on mood, the stress response, and brain function and behavior in women with premenstrual syndrome. Previously this study has demonstrated leuprolide acetate (Lupron (Registered Trademark)) to be an effective treatment for PMS. The current 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 women with PMS. PMS is a condition characterized by changes in mood and behavior that occur during the second phase of the normal menstrual cycle (luteal phase). This study will investigate possible hormonal causes of PMS by temporarily stopping the menstrual cycle with leuprolide acetate and then giving, in sequence, the menstrual cycle hormones progesterone and estrogen. The results of these hormonal studies will be compared between women with PMS and healthy volunteers without PMS (see also protocol 92-M-0174). 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 by skin patch
Placebo given intramuscularly monthly
Placebo vaginal suppository