drugset / Trial / NCT04190927

A New Hormone Replacement Paradigm: Physiologic Restoration Study

NCT04190927

Phase 4 Unknown 100 enrolled Women's Hormone Network
NaSingle-groupOpen-labelTreatment

Summary

This is a three-year, prospective, observational study looking at the benefits of rhythmically dosed, bio-identical hormones compounded in a carrier cream in 100 symptomatic peri and postmenopausal women. This study will measure changes in cognition, mood, quality of life, endocrine health, bone mineral density, and reduction of the symptoms of menopause and any adverse effects. The objectives of this study are to show that rhythmic dosing of bio-identical hormones that mimic a menstrual cycle, are possible, and may be more beneficial and have fewer side effects than the current standard of care for treating the symptoms of menopause.

Timeline

Start
2020-06-01
Primary completion
2023-06-01
Completion
2023-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Estradiol Other / unclassified Topical
Subject Progesterone Other / unclassified Topical

Indications