Estetrol drospirenone effective as firstline endometriosis treatment: Study
Endometriosis is a chronic inflammatory condition affecting women of reproductive age that worsens their quality of life (QoL) because of various chronic pelvic pain symptoms, including dysmenorrhea, intermenstrual lower abdominal and back pain, defecation pain, and dyspareunia. Guidelines recommend combination estrogen and progestin drugs as the first-line therapy. Ethinyl estradiol (EE), a widely used estrogen in combined oral contraceptives (OCs), affects the vascular endothelium and liver protein synthesis related to hemostasis and blood pressure, increasing the risk of cardiovascular complications. Estetrol (E4) is a native estrogen produced in fetal liver that specifically binds to estrogen receptors (ERs) a and b. Estradiol activates both nuclear and membrane ERa equally, whereas E4 acts as an agonist of nuclear ERa and an ERa-dependent membrane-initiated steroid signaling antagonist. Therefore, E4 was termed the first native estrogen with selective tissue activity and was classified differently from selective ER modulators. The combination of E4 (15 mg)/drospirenone (DRSP) (3 mg) achieved sufficient ovulation suppression, with a low frequency of unscheduled bleeding and minimal effects on lipid and glucose metabolism and hemostasis.
Estetrol/drospirenone has lower estrogenic activity than EE-based OCs, possibly with decreased thromboembolic risk. To evaluate the efficacy and safety of 24-week cyclic administration of estetrol (E4) (15 mg)/drospirenone (DRSP) (3 mg) in Japanese patients with endometriosis, a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study was carried across Twenty-five study centers in Japan. A total of 162 Japanese women were diagnosed with endometriosis. Participants were randomly allocated to the E4/DRSP group or the placebo group. In the E4/DRSP group, participants were orally administered one tablet containing E4 (15 mg) and DRSP (3 mg) daily for 24 days, followed by one placebo tablet for 4 days for a hormone-free interval, constituting a 1-cycle regimen. One placebo tablet was administered once daily for 28 days to participants in the placebo group. The treatments were continued for six cycles (24 weeks) throughout the confirmatory period. Changes in visual analogue scale (VAS) scores for the most severe pelvic pain (lower abdominal and back pain) from baseline to six treatment cycles at the end of the confirmatory study period were studied.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.