Ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen for the management of endometriosis-associated pelvic pain: a randomized controlled trial
| Autor: | Joerg Elliesen, Tasuku Harada, Saori Kosaka, Masanobu Yasuda, Makoto Ito, Mikio Momoeda |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
medicine.medical_specialty Time Factors Visual analogue scale Endometriosis Ethinyl Estradiol Pelvic Pain Placebo Severity of Illness Index Drug Administration Schedule law.invention 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Japan Randomized controlled trial law medicine Humans 030212 general & internal medicine Pain Measurement 030219 obstetrics & reproductive medicine business.industry Pelvic pain Obstetrics and Gynecology Drospirenone medicine.disease Surgery Clinical trial Contraceptives Oral Combined Treatment Outcome Reproductive Medicine Dienogest chemistry Androstenes Female medicine.symptom business medicine.drug |
| Zdroj: | Fertility and Sterility. 108:798-805 |
| ISSN: | 0015-0282 |
| DOI: | 10.1016/j.fertnstert.2017.07.1165 |
| Popis: | Objective To investigate the efficacy and safety of ethinylestradiol 20 μg/drospirenone 3 mg in a flexible extended regimen (Flexible MIB ) compared with placebo to treat endometriosis-associated pelvic pain (EAPP). Design A phase 3, randomized, double-blind, placebo-controlled, parallel-group study, consisting of a 24-week double-blind treatment phase followed by a 28-week open-label extension phase with an unblinded reference arm. Setting Thirty-two centers. Patient(s) A total of 312 patients with endometriosis. Intervention(s) Patients were randomized to Flexible MIB , placebo, or dienogest. The Flexible MIB and placebo arms received 1 tablet per day continuously for 120 days, with a 4-day tablet-free interval either after 120 days or after ≥3 consecutive days of spotting and/or bleeding on days 25–120. After 24 weeks, placebo recipients were changed to Flexible MIB . Patients randomized to dienogest received 2 mg/d for 52 weeks in an unblinded reference arm. Main Outcome Measure(s) Absolute change in the most severe EAPP based on visual analog scale scores from the baseline observation phase to the end of the double-blind treatment phase. Result(s) Compared with placebo, Flexible MIB significantly reduced the most severe EAPP (mean difference in visual analog scale score: −26.3 mm). Flexible MIB also improved other endometriosis-associated pain and gynecologic findings and reduced the size of endometriomas. Conclusion(s) Flexible MIB improved EAPP and was well tolerated, suggesting it may be a new alternative for managing endometriosis. Clinical Trials Registration Number NCT01697111. |
| Databáze: | OpenAIRE |
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