Rhythmic Estradiol and Bone Health

What this trial studies

The goal of this randomized-controlled trial is to compare the effect of rhythmic estrogen treatment to continuous estrogen treatment on bone turnover in healthy postmenopausal women. The main question it aims to answer are: • Does rhythmic estrogen lead to increased bone formation in healthy postmenopausal women, compared to continuous estrogen? Participants will receive one of the following treatments for a duration of 16 weeks: \- Rhythmic estradiol: Alternating 4-week cycles consisting of transdermal 17-β-estradiol 25μg/24hrs for two weeks, followed by two weeks of transdermal 17-β-estradiol 50μg/24hrs. Estradiol therapy will be combined with continuous oral micronized progesterone 100mg once daily.

Conditions in scope

• Osteoporosis Risk
• Menopause

Interventions

• Estradiol patch (Drug) — Transdermal patch of estradiol
• Progesterone (Drug) — Oral progesterone capsules 100mg/day

Who can join

Women only · Ages 45 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

• Postmenopausal, defined as final menstrual cycle more than 1 years prior to inclusion and FSH\>30 IU/L
• Final menstrual cycle \< 10 years prior to inclusion

Exclusion criteria

• Contra-indication for estrogen and/or progesterone therapy
• First-grade family member with inherited thrombophilia or history of venous thromboembolism under the age of 60 years
• Hysterectomy
• Premature menopause (menopause age \<40 years)
• Known hypersensitivity to the excipients in the estradiol patch or progesterone capsule
• Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) in the past 12 months
• Presence or history of any clinically relevant metabolic, endocrinological, hepatic, renal, cardiovascular, gastrointestinal, or respiratory conditions, history of bone disease or bone marrow disease, known vitamin D deficiency (25-OH vitamin D \<30 nmol/L)
• Recent fracture (\<12 months)

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: PHASE4
• Start date: 2023-07-19
• Primary completion: 2024-10-21
• Last update posted: 2025-02-05
• First posted: 2023-06-15

Sponsor & contact

Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Serum P1NP (The difference in P1NP between treatment arms after 2 weeks)
  The interaction between treatment and time on serum P1NP
• Serum P1NP (The difference in P1NP between treatment arms after 4 weeks)
  The interaction between treatment and time on serum P1NP
• Serum P1NP (The difference in P1NP between treatment arms after 6 weeks)
  The interaction between treatment and time on serum P1NP
• Serum P1NP (The difference in P1NP between treatment arms after 8 weeks)
  The interaction between treatment and time on serum P1NP
• Serum P1NP (The difference in P1NP between treatment arms after 10 weeks)
  The interaction between treatment and time on serum P1NP

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.