• 1 Department of Obstetrics and Gynecology, Gynecologic Endocrinology Unit, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 2 Department of Obstetrics and Gynecology, Faculty of Medicine, Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia
  • 3 Department of Obstetrics and Gynecology, Sabah Women's and Children's Hospital, Kota Kinabalu, Malaysia
  • 4 Department of Obstetrics and Gynecology Reproductive Endocrinology and Fertility, St. Luke's Medical Center, Philippine General Hospital, Metro Manila, Philippines
  • 5 Department of Obstetrics and Gynecology, The Catholic University Of Korea, Seoul St. Mary's Hospital, Seoul, Korea
  • 6 Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea
  • 7 Department of Obstetrics and Gynecology, Hermina Pandanaran Hospital, Semarang, Indonesia
  • 8 Bayer Pharma AG, Wuppertal, Germany
  • 9 Former employee of Bayer AG, Seoul, Republic of Korea
  • 10 Division of Gynecologic Endocrinology and Infertility, Department of Obstetrics and Gynecology, Severance Hospital,Yonsei University, 50-1 Yonsei-ro, Seodaemun-gu, 120-752, Seoul, Republic of Korea.
BMC Womens Health, 2019 05 16;19(1):68.
PMID: 31096979 DOI: 10.1186/s12905-019-0758-6


BACKGROUND: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL.

METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.

RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.

CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.

TRIAL REGISTRATION: Name of registry: Clinical Trials registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.