An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open-label multicenter clinical study.

ABSTRACT:

Purpose

To assess the efficacy and safety of dydrogesterone in Japanese women with ovarian endometrioma in a real-world setting.

Methods

The post-marketing study involved 15 sites in Japan. Dydrogesterone 10 mg twice daily orally was administered for 21 days (day 5-25 of each menstrual cycle) for 4 cycles. The primary outcome measure was the change in ovarian endometrioma volume from baseline. Secondary outcome measures included total dysmenorrhea score (0 = absent to 3 = severe), severity of dysmenorrhea pain [0-10cm visual analog scale (VAS)], serum carbohydrate antigen 125 (CA-125) levels, and safety.

Results

The study group comprised women with an endometrioma aged 20 to 49 (47.4% cases aged ≥40 years). Endometrioma volume was reduced in 50% (26/52), unchanged in

SUBMITTER: Kitawaki J 

PROVIDER: S-EPMC8254175 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature