Can a patch beat a pill? new study aims to strengthen bones in women with hormone imbalance
NCT ID NCT07010146
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This study looks at whether natural estrogen given through a skin patch improves bone strength more than natural estrogen pills or a synthetic birth control patch in women aged 14–30 with functional hypothalamic amenorrhea (missed periods due to stress, low weight, or exercise). Participants take estrogen for one year, plus calcium and vitamin D, and attend four study visits. The goal is to find the best way to protect bones in this condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
May 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
14 to 30 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left) * Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if sexually active. Note: Women who receive a progestin implant for contraception after study enrollment will be allowed to continue and will not be excluded from study. * Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \<10 ng/mL above upper limit of normal, potassium between 3.0-5.0, ALT ≤3 times upper limit of normal, LDL ≤190 mg/dl. * Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a TSH within 2x the upper limit of normal for at least a month preceding the baseline study visit. * Menstrual criteria: \< 3 menses in the preceding 6 months. Exclusion Criteria: * Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus 1. Primary thyroid dysfunction will be defined as a TSH level more than 2X the upper limit of normal per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies. 2. Patients with hypothyroidism will be excluded if not appropriately treated with levothyroxine and if they do not have a TSH level within 2X the upper limit of normal for at least a month preceding the baseline study visit, given possible effects on the reproductive axis and bone. * Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation) * Substance use disorder; current smoker (\>10 cigarettes per day) * Pregnant, planning to become pregnant within 12 months of the end of treatment and/or breastfeeding * Hypertension or use of anti-hypertensive medications * Other conditions causing oligo-amenorrhea such as PCOS, premature ovarian insufficiency * Known sensitivity or absolute contraindication to any component of study medications (high risk thromboembolic disease, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute viral hepatitis, decompensated cirrhosis, undiagnosed abnormal uterine bleeding * BMI ≥ 25 kg/m2 (efficacy of the contraceptive patch being used in the study is lower at higher BMIs)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bone density are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Virginia
RECRUITINGCharlottesville, Virginia, 22908, United States
-
University of Virginia Medical Center
RECRUITINGCharlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a natural compound help preserve jawbone after tooth loss?
- Can keeping a tooth fragment save your jawbone after an implant?
- Hidden deficiencies in black college athletes under the microscope
- Bite balance may keep jawbone strong in denture wearers
- Shake it off? study tests vibration therapy for stronger bones in menopause
- Lifting weights, not rest: new study tests exercise as treatment for lost periods