Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy
Summary
Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus. The purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone. This prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period. The results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.
Timeline
- Start
- 2026-04
- Primary completion
- 2027-10
- Completion
- 2027-10
Publications
- Background Graham S, Archer DF, Simon JA, Ohleth KM, Bernick B. Review of menopausal hormone therapy with estradiol and progesterone versus other estrogens and progestins. Gynecol Endocrinol. 2022 Nov;38(11):891-910. doi: 10.1080/09513590.2022.2118254. Epub 2022 Sep 8.
- Background Hipolito Rodrigues MA, Gompel A. Micronized progesterone, progestins, and menopause hormone therapy. Women Health. 2021 Jan;61(1):3-14. doi: 10.1080/03630242.2020.1824956. Epub 2020 Sep 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dydrogesterone | Other / unclassified | 10 mg | Oral |
| Subject | Progesterone | Other / unclassified | 200 mg | Other |
| Background | Estradiol | Other / unclassified | — | Other |
Indications
No indication recorded.