NCT00005011

Combined Hormone Replacement in Menstrually-Related Mood Disorders

Completed Last updated 16 December 2019

What this trial tests

trial in Premenstrual Syndrome in 22 participants. Completed in 28 October 2016.

Timeline

28 March 2000

28 October 2016

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	22
Start date	28 March 2000
Estimated completion	28 October 2016
Sites	1 location across United States

Conditions studied

• Premenstrual Syndrome — all drugs for Premenstrual Syndrome →
• Depression — all drugs for Depression →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 18 to 50, female only, with Premenstrual Syndrome or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study investigates the effects on symptoms of combined treatment with estrogen and progesterone in women with severe premenstrual syndrome (PMDD).

Studies indicate that women with PMS experience improvement in symptoms following treatment with leuprolide acetate, when estrogen and progesterone levels are low. Women with PMS, but not women without the disorder, experience a return of symptoms within approximately a week after re-exposure to either estrogen or progesterone. The cause of this hormone-induced depression remains unclear. It is not known whether this depressed mood is due simply to the change in the levels of estrogen and progesterone and whether it would remit following continued exposure to stable levels of estrogen and progesterone. This study will determine whether the maintenance of stable hormone levels will prevent mood disturbances in women with PMS.

Participants in this study will receive leuprolide acetate injections once a month for up to 6 months. After 2 months, women whose symptoms have improved will receive a skin patch containing either estrogen or placebo (an inactive substance) and will be asked to take daily suppositories containing either progesterone or placebo. Women whose symptoms of PMS do not respond to leuprolide treatment after 2 months will end the study and be offered other treatment. Participants will be seen by a nurse in the clinic every two weeks and will fill out ratings and have blood drawn to measure hormone levels.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Premenstrual Dysphoric Disorder Symptoms Following Ovarian Suppression: Triggered by Change in Ovarian Steroid Levels But Not Continuous Stable Levels.
   Schmidt PJ, Martinez PE, Nieman LK, Koziol DE, et al · · 2017 · cited 141× · PMID 28427285 · DOI 10.1176/appi.ajp.2017.16101113