Pelvic pain and quality of life of women with endometriosis during quadriphasic estradiol valerate/dienogest oral contraceptive: a patient-preference prospective 24-week pilot study

Reprod Sci. 2015 May;22(5):626-32. doi: 10.1177/1933719114556488. Epub 2014 Nov 13.

Abstract

Objective: The progestin dienogest (DNG) given alone effectively reduces pelvic pain of women with endometriosis. It is not clear whether the same occurs when DNG is associated with estradiol (E2).

Design: Patient preference prospective observational study.

Setting: Outpatient centre of university hospital.

Patients: 40 patients with endometriosis and menstrual pain.

Interventions: 24-week treatment with a quadriphasic association of E2 valerate (E2V) and DNG or a nonsteroidal anti-inflammatory drug (NSAID) to be used only in case of pain (ketoprofene 200-mg tablets).

Main outcome measures: Menstrual pain and, when present, intermenstrual pain, and dyspareunia were investigated by means of a 10-cm visual analogue scale (VAS). Quality of life was investigated by the short form 36 (SF-36) of the health-related quality of life questionnaire.

Results: Final study group consists of 34 patients, 19 in the E2V/DNG group and 15 in the NSAID group. After 24 weeks, no significant modification of menstrual pain, intermenstrual pain, dyspareunia, or SF-36 score was observed in the NSAID group. Treatment with E2V/DNG reduced the VAS score of menstrual pain by 61% (P < .0001). In the subgroups of women with intermenstrual pain or dyspareunia, E2V/DNG reduced these complaints by 65% (P = .013) and 52% (P = .016), respectively. The reduction in menstrual (P = .0001) and intermenstrual pain (p = 0.03) was significantly greater during E2V/DNG than NSAID. Quality of life improved during E2V/DNG (P = .0002), both in physical (P = .0003) and mental domains (P = .0065). Only a few minor adverse effects were described during E2V/DNG, and none caused withdrawal from treatment.

Conclusion: In patients with endometriosis and pelvic pain, the 24-week administration of the quadriphasic association of E2V/DNG decreases pelvic pain and improves quality of life.

Keywords: NSAID; chronic pelvic pain; combined oral contraceptive; dienogest; dysmenorrhea; dyspareunia; endometriosis; estradiol valerate; hormonal contraception; ketoprofene; quality of life.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Contraceptives, Oral, Hormonal / administration & dosage*
  • Contraceptives, Oral, Hormonal / adverse effects
  • Drug Combinations
  • Dysmenorrhea / diagnosis
  • Dysmenorrhea / drug therapy*
  • Dysmenorrhea / psychology
  • Endometriosis / diagnosis
  • Endometriosis / drug therapy*
  • Endometriosis / psychology
  • Estradiol / administration & dosage
  • Estradiol / adverse effects
  • Estradiol / analogs & derivatives*
  • Female
  • Hospitals, University
  • Humans
  • Italy
  • Nandrolone / administration & dosage
  • Nandrolone / adverse effects
  • Nandrolone / analogs & derivatives*
  • Pain Measurement
  • Patient Preference*
  • Pelvic Pain / diagnosis
  • Pelvic Pain / drug therapy*
  • Pelvic Pain / psychology
  • Pilot Projects
  • Prospective Studies
  • Quality of Life*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Substances

  • Contraceptives, Oral, Hormonal
  • Drug Combinations
  • estradiol valerate-dienogest
  • Estradiol
  • Nandrolone