NCT05903820CompletedPhase 4
Rhythmic Estradiol and Bone Health
The Effect of Low-dose Rhythmic 17-β-estradiol Administration on Bone Turnover in Postmenopausal Women
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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. * Low-dose continuous estradiol: Continuous transdermal 17-β-estradiol 25μg/24hrs, combined with continuous oral micronized progesterone 100mg daily once daily. * Standard-dose continuous estradiol: Continuous transdermal 17-β-estradiol 50μg/24hrs, combined with continuous oral micronized progesterone 100mg daily once daily. If there is a comparison group: Researchers will compare rhythmic estradiol to continuous estradiol to see if rhythmic estradiol improves bone formation in postmenopausal women.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 15 May 2023
- Start date
- 19 Jul 2023
- Primary completion date
- 21 Oct 2024
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Osteoporosis
- NCT number
- NCT05903820
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 48
- From 19 Jul 2023 to the primary completion date, 21 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contra-indication for estrogen and/or progesterone therapy
- Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) in the past 12 months
- Use of drugs including herbal medicine known to affect bone metabolism (e.g. corticosteroids) or to interfere with cytochrome P450 enzyme (CYP) pathways. Exceptions are occasional use of paracetamol, ibuprofen, acetylsalicylic acid or topical medication
Other illness
- Known hypersensitivity to the excipients in the estradiol patch or progesterone capsule
- 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)
Age
- First-grade family member with inherited thrombophilia or history of venous thromboembolism under the age of 60 years
- Premature menopause (menopause age \<40 years)
Other
- Hysterectomy
- Recent fracture (\<12 months)
- BMI \<20 or BMI ≥30
Who the study is looking for
- 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
Age in the registry: 45 years to 60 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.