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Role of Estrogen on Skeletal Outcomes in FHA
NCT07010146 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control. Participants will: Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin) Take provided calcium and vitamin D supplements Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include: History and Physical Exams Lab Work Imaging studies Questionnaires Dietary recalls
Conditions Studied
Interventions
- DRUG transdermal 17β-E2 with cyclic progestin
- DRUG oral 17β-E2 with cyclic progestin
- DRUG transdermal EE+LNG
Study Locations (2)
Virginia
- University of Virginia Medical Center — Charlottesville
- University of Virginia — Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2030-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07010146
The ClinicalTrials.gov registry entry for NCT07010146 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 392 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Bone Density appearing as the primary indexed condition, and to 3 interventions — of which transdermal 17β-E2 with cyclic progestin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07010146 reports 2 study locations spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07010146 about?
NCT07010146 is a clinical study titled "Role of Estrogen on Skeletal Outcomes in FHA". The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl...
What is the current status of trial NCT07010146?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-07-01. Estimated completion is 2030-07-01.
What conditions does trial NCT07010146 study?
This clinical trial studies the following conditions: Bone Density, Bone Strength, FHA (Functional Hypothalamic Amenorrhea). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07010146?
The interventions under investigation include: transdermal 17β-E2 with cyclic progestin (DRUG), oral 17β-E2 with cyclic progestin (DRUG), transdermal EE+LNG (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07010146?
This trial is sponsored by University of Virginia, which has 392 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07010146 being conducted?
This trial has 2 study locations across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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