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A New Hormone Replacement Paradigm: Physiologic Restoration Study

NCT04190927 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-04-01

No results posted yet for this study

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.

Conditions

  • Menopause
  • Perimenopausal Disorder
  • Menopause Related Conditions

Interventions

BIOLOGICAL

Compounded topical estradiol and compounded topical progesterone in a carrier cream

Apply topical compounded estradiol and progesterone in the amount prescribed twice daily for each day of the 28 day lunar or menstrual cycle. Repeat each cycle month. Make note of any AE's so that modifications in dosing can be made.

Sponsors & Collaborators

  • Women's Hormone Network

    lead OTHER

Principal Investigators

  • Julie Taguchi, MD · Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2023-06-01
Completion
2023-08-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04190927 on ClinicalTrials.gov