A New Hormone Replacement Paradigm: Physiologic Restoration Study

NCT04190927 | Unknown Phase 4 FDA Drug

• 2 other identifiers: WHN 13/1319-71ix
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Menopause; Hormone Replacement Therapy; Bioidentical HRT; Transdermal HRT; Rhythmic Dosing; Physiologic Restoration; Biomimetic HRT

Outcome Measures

Primary Outcomes (3)

• Change in Symptoms of Menopause

  Measure changes in hormone levels and blood chemistry, assess changes in mood and cognitive function, measure changes in brain structure

  36 months

• Compliance of this HRT Regimen

  Measure compliance of patients on this specific HRT regimen

  36 months

• Change in Bone Mineral Density

  Bone Mineral Density will be monitored for changes

  36 months

Secondary Outcomes (1)

• Incidence of adverse effects

  36 months

Study Arms (1)

Treatment

EXPERIMENTAL

All patients will be symptomatic peri or post menopausal and will all be started on the same protocol. The Dosing schedule of topical estradiol and topical progesterone will be modified for each subject in the first three months to address individual symptoms. The dosing will be relatively unique to each patient. Patients will remain on their dosing schedule for the remainder of the three year study and will be assessed during at the end of the study for changes in mood, symptoms of menopause, breast health, BMD and thickness of uterine lining .

Biological: Compounded topical estradiol and compounded topical progesterone in a carrier cream

Interventions

Compounded topical estradiol and compounded topical progesterone in a carrier cream BIOLOGICAL

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.

Treatment

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic perimenopausal or menopausal women as determined by symptoms, history, or labs that confirm menopause status.
• Any women interested in physiologic restoration for HRT replacement.
• Women with a history of breast, endometrial or ovarian cancer who are seeking HRT regardless of their diagnosis and recommendations not to have HRT. They must understand the risk and give informed dissent.
• Hysterectomy.

You may not qualify if:

• Women who are pregnant and or breastfeeding.
• Women who may be allergic to the base used for compounding.
• Previous recent (\< 12 months) rhythmic dosing hormone protocol.

Sponsors & Collaborators

• Women's Hormone Network: lead

Related Links

• website for the Women's Hormone Network

Study Officials

• Julie Taguchi, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Taguchi, MD

CONTACT

805 879-0670; jtaguchi@womenshormonenetwork.org

Shelley S Meaney

CONTACT

8057085206; catsmeaney@aol.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational, single arm, prospective using a new dosing regimen of an existing biological drug.

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 9, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: During the study, at years one and two and at the conclusion of the study. Data will be available indefinitely.
• Access Criteria: Requests for IPD will be submitted and reviewed by the Women's Hormone Network.