Treatment of symptomatic rectovaginal endometriosis with an estrogen-progestogen combination versus low-dose norethindrone acetate.
OBJECTIVE
To evaluate the efficacy, safety, and tolerability of an estrogen-progestogen combination versus low-dose norethindrone acetate in the treatment of persistent pain after surgery for symptomatic rectovaginal endometriosis.


METHODS
Randomized controlled trial.


METHODS
Academic center.


METHODS
Ninety women with recurrent moderate or severe pelvic pain after unsuccessful conservative surgery for symptomatic rectovaginal endometriosis.


METHODS
Twelve-month, continuous treatment with oral ethinyl E2, 0.01 mg, plus cyproterone acetate, 3 mg/day, or norethindrone acetate, 2.5 mg/day.


METHODS
Degree of satisfaction with therapy.


RESULTS
Seven women in the ethinyl E2 plus cyproterone acetate arm and five in the norethindrone acetate arm withdrew because of side effects (n=5), treatment inefficacy (n=6), or loss to follow-up (n=1). At 12 months, dysmenorrhea, deep dyspareunia, nonmenstrual pelvic pain, and dyschezia scores were substantially reduced without major between-group differences. Both regimens induced minor unfavorable variations in the serum lipid profile. According to an intention-to-treat analysis, 28 (62%) out of 45 patients in the ethinyl E2 plus cyproterone acetate group and 33 (73%) out of 45 in the norethindrone acetate group were satisfied with the treatment received.


CONCLUSIONS
Low-dose norethindrone acetate could be considered an effective, tolerable, and inexpensive first-choice medical alternative to repeat surgery for treating symptomatic rectovaginal endometriotic lesions in patients who do not seek conception.
Vercellini
Paolo
P
Clinica Ostetrica e Ginecologica I, University of Milan, Istituto Luigi Mangiagalli, Milan, Italy. paolo.vercellini@unimi.it
Pietropaolo
Giuliana
G
De Giorgi
Olga
O
Pasin
Roberta
R
Chiodini
Annalisa
A
Crosignani
Pier Giorgio
PG
D000293:Adolescent; D000328:Adult; D016001:Confidence Intervals; D004359:Drug Therapy, Combination; D004715:Endometriosis / Q000188:drug therapy* / Q000473:pathology; D015914:Estrogen Replacement Therapy / Q000379:methods*; D004967:Estrogens / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009640:Norethindrone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077563:Norethindrone Acetate; D010147:Pain Measurement / Q000187:drug effects; D011372:Progestins / Q000008:administration & dosage*; D012002:Rectal Diseases / Q000188:drug therapy* / Q000473:pathology; D018709:Statistics, Nonparametric; D014623:Vaginal Diseases / Q000188:drug therapy* / Q000473:pathology
D004967:Estrogens; D011372:Progestins; D000077563:Norethindrone Acetate; D009640:Norethindrone