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.
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).


METHODS
Patient preference prospective observational study.


METHODS
Outpatient centre of university hospital.


METHODS
40 patients with endometriosis and menstrual pain.


METHODS
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).


METHODS
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.


CONCLUSIONS
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.
Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit, Azienda Policlinico of Modena, Italy.
Giovanni
G
Grandi
Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit, Azienda Policlinico of Modena, Italy.
Anjeza
A
Xholli
Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit, Azienda Policlinico of Modena, Italy.
Antonella
A
Napolitano
Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit, Azienda Policlinico of Modena, Italy.
Federica
F
Palma
Department of Obstetrics Gynecology and Pediatrics, Obstetrics and Gynecology Unit, Azienda Policlinico of Modena, Italy cagnacci@unimore.it.
Angelo
A
Cagnacci
D000328:Adult; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D004412:Dysmenorrhea / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004715:Endometriosis / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006785:Hospitals, University; D006801:Humans; D007558:Italy; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D010147:Pain Measurement; D057240:Patient Preference; D017699:Pelvic Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D010865:Pilot Projects; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D003278:Contraceptives, Oral, Hormonal; D004338:Drug Combinations; C454300:estradiol valerate-dienogest; D004958:Estradiol; D009277:Nandrolone
NSAID; chronic pelvic pain; combined oral contraceptive; dienogest; dysmenorrhea; dyspareunia; endometriosis; estradiol valerate; hormonal contraception; ketoprofene; quality of life