Hormone Replacement for Premature Ovarian Insufficiency

Withdrawn before enrolling · Phase 3

Conditions studied: Primary Ovarian Insufficiency

In brief

The investigators intend to establish feasibility/acceptability of a pilot randomized trial comparing hormone replacement therapy (HRT) and combined oral contraceptives (COCs) in women with premature ovarian insufficiency to estimate differences in quality of life (QOL) and serum hormone assays and markers of bone turnover/cardiovascular risk. At baseline, QOL survey will be administered and serum testing performed. Patients then randomized to HRT or COCs. Repeat testing will be performed after 3 and 6 months.

Key facts

Study ID: NCT02922348
Run by: University of Pennsylvania
People needed: 0
Starts: 2016-03-01
Expected to finish: 2018-12-01
Last updated by the study team: 2019-07-05

Who can join

Age: 14 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Female patients,
Between 14-45 years of age
Post-menarchal
Presence of uterus
POI as defined by: change in menstrual function (oligomenorrhea and/or amenorrhea), elevated serum serum follicle stimulating hormone (FSH), low serum estradiol concentrations, or estrogen deficiency symptoms.

You may not qualify if…

Pregnancy or lactation within previous 3 months
Use of hormonal contraception or replacement within previous 3 months
Any contraindication to oral contraceptive pills or hormone replacement therapy per the current drug labels. These could include, but are not limited to: history of venous thromboembolism,estrogen-sensitive cancer history, regular cigarette smoking and history of or active liver disease, etc.
Patients will be screened for pregnancy with a urine HCG test at time of screening

Where it is running

Penn Fertility Care — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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