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Phase 3CompletedAge-related condition

A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms (REPLENISH)

A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

Sponsor
TherapeuticsMD (Industry)
Enrollment
1,845 enrolled
Conditions
Menopause
Interventions
Estradiol; Progesterone; Placebo
Ages
adults, older adults
Registry
NCT01942668

Full record on ClinicalTrials.gov

From the registry

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

Primary outcomes

  • Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
  • Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
  • Primary Safety Endpoint: Endometrial Protection - Hyperplasia

History

  1. Results first posted

  2. Last registry update

  3. Primary completion

  4. Registered

  5. Started