Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study

Introduction Dysmenorrhea and endometriosis are common gynecologic disorders among women of reproductive age that significantly impact health-related quality of life (HRQL) as well as productivity. Although there are treatment options listed in Japanese guidelines, a gap remains in unmet medical nee...

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Published in:Advances in therapy Vol. 39; no. 11; pp. 5087 - 5104
Main Authors: Yoshino, Osamu, Suzukamo, Yoshimi, Yoshihara, Keisuke, Takahashi, Noriko
Format: Journal Article
Language:English
Published: Cheshire Springer Healthcare 01.11.2022
Subjects:
Adult
Androstenes
Cardiology
Dysmenorrhea - complications
Dysmenorrhea - etiology
Endocrinology
Endometriosis - complications
Endometriosis - drug therapy
Female
Humans
Internal Medicine
Japan
Medicine
Medicine & Public Health
NCT
NCT03126747
Oncology
Original Research
Pelvic Pain - drug therapy
Pelvic Pain - etiology
Pharmacology/Toxicology
Quality of Life
Rheumatology
Japan
Endometriosis
Product surveillance, post-marketing
Patient-reported outcome measures
Dysmenorrhea
Quality of life
ISSN:0741-238X, 1865-8652, 1865-8652
Online Access:Get full text
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Summary:Introduction Dysmenorrhea and endometriosis are common gynecologic disorders among women of reproductive age that significantly impact health-related quality of life (HRQL) as well as productivity. Although there are treatment options listed in Japanese guidelines, a gap remains in unmet medical needs for maximizing treatment outcome. The extended regimen of ethinylestradiol and drospirenone (EE/DRSP) (taken daily for up to 120 consecutive days) has been available in Japan for treating dysmenorrhea and/or endometriosis-associated pain since 2016. Yet, the effectiveness of its usage on HRQL has not been investigated elsewhere to date. Therefore, in this study, we aim to observe changes in HRQL of Japanese women treated with an extended regimen of EE/DRSP for dysmenorrhea and/or endometriosis-associated pain. Methods As part of a 2-year post-marketing surveillance study, women with dysmenorrhea or endometriosis-associated pelvic pain were prescribed extended EE/DRSP during routine clinical practice. Data were collected 1 month before and 3 and 6 months after initiating treatment. Primary outcomes were the Menstrual Distress Questionnaire (MDQ) (before, during, and after menstruation) in patients with dysmenorrhea, and the Endometriosis Impact Scale (EIS) and European Quality of Life 5-dimensions 5-level instrument (EQ-5D-5L) in patients with endometriosis. Results The study cohort included 315 patients (mean age 28.9 years) with dysmenorrhea and 262 patients (mean age 31.3 years) with endometriosis. Mean MDQ total scores before and during menstruation decreased significantly after 6 months with extended EE/DRSP; there was no improvement in after-menstruation MDQ score. Mean EIS domain scores improved significantly by 6 months, with improvement in most EIS individual item scores. Mean EQ-5D-5L scores increased slightly during 6 months of treatment. Conclusions Extended EE/DRSP treatment improved HRQL outcomes in Japanese women with dysmenorrhea or endometriosis-associated pelvic pain. Trial Registration Registered at ClinicalTrials.gov (NCT03126747) on June 2017.
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ISSN:0741-238X
1865-8652
1865-8652
DOI:10.1007/s12325-022-02301-3