Role of Estrogen on Skeletal Outcomes in FHA

Launched by UNIVERSITY OF VIRGINIA · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different forms of estrogen on bone health in young women who have Functional Hypothalamic Amenorrhea (FHA), a condition that can disrupt menstrual cycles and affect bone strength. The researchers want to determine if a natural form of estrogen, applied as a patch on the skin, is more effective at improving bone strength over one year compared to taking the same natural estrogen as a pill or using a synthetic estrogen patch that also acts as birth control.

To participate, women aged 14 to 25 who have had fewer than three menstrual periods in the last six months may be eligible. Participants will receive one of the estrogen treatments for a year and will attend four study visits during that time to undergo health checks, lab tests, and imaging studies. They will also take calcium and vitamin D supplements. It's important to know that participants will be assigned to a treatment group randomly, meaning they won't be able to choose which form of estrogen they receive. The study is not yet recruiting, but it's a valuable opportunity for eligible young women to contribute to understanding better treatments for bone health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females, age 14-25 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
• • Biochemical criteria: negative βHCG (pregnancy test), normal TSH, prolactin, potassium, ALT ≤3 times upper limit of normal, LDL ≤190 mg/dl
• • 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
• • 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)