CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Leuprolide Acetate 3.75 +4 moredrug
Likely dose
Leuprolide acetate 3.75 mg intramuscularly monthly for 8-12 weeks; Transdermal estradiol 100 mcg/day; Progesterone 200 mg vaginally twice dailyAI-extracted
Key inclusion· 5
  • Female aged 18-50 years
  • Not pregnant
  • Good medical health
  • Medication free (except as specified)
Key exclusion· 17
  • 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.

Search/NCT00001322
NCT00001322Phase 2Completed

The Central Nervous System Effects of Pharmacologically Induced Hypogonadotropic Hypogonadism With and Without Estrogen and Progesterone Replacement

National Institute of Mental Health (NIMH)·interventional·Posted Nov 4, 1999·Updated Mar 22, 2022

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 4, 1999
Enrollment StartJun 9, 1994
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 25.7 yearsPosted 26.7 years ago

Interventions

Leuprolide Acetate 3.75drug

Eight to 12 weeks of GnRH agonist, Leuprolide Acetate 3.75 mg given intramuscularly monthly

Estradioldrug

Transdermal Estradiol, 100mcg/day by skin patch

Progesteronedrug

Progesterone suppository, 200mg vaginally twice/day

Placebo suppositorydrug

Placebo suppository twice daily

Placebo patchdrug

Placebo by skin patch