drugset / Trial / NCT02922348
Hormone Replacement for Premature Ovarian Insufficiency
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2016-03-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 100 ug | Other |
| Subject | Estradiol | Other / unclassified | 2 mg | Other |
| Subject | Norgestimate | Small molecule | 0.25 mg | Oral |
| Subject | Progesterone | Other / unclassified | 200 mg | — |
| Subject | ethinyl estradiol | Small molecule | 0.035 mg | Oral |
| Subject | medroxyprogesterone acetate | Other / unclassified | 10 mg | — |