Gonadotropin-releasing hormone agonist plus "add-back" hormone replacement therapy for treatment of endometriosis: a prospective, randomized, placebo-controlled, double-blind trial.
OBJECTIVE
To assess the effect of add-back therapy with continuous combined estrogen-progestin on the GnRH agonist-induced hypoestrogenic state and its effectiveness in healing of endometriotic lesions.


METHODS
A prospective, randomized, placebo-controlled, double-blind trial.


METHODS
Multiple centers in The Netherlands.


METHODS
41 premenopausal women with laparoscopically diagnosed endometriosis (revised American Fertility Society scores >/=2).


METHODS
Patients were randomly assigned to receive a subcutaneous depot formulation of goserelin, 3. 6 mg, every 4 weeks, plus oral placebo or oral continuous combined estradiol-norethisterone acetate add-back therapy daily for 24 weeks.


METHODS
Endometriosis response, bone mineral density, transvaginal ultrasonographic changes, endocrinologic effects, and subjective side effects.


RESULTS
The number of endometriotic implants was significantly reduced in both groups. In the group that received GnRH agonist plus placebo, bone mineral density of the lumbar spine decreased by 5.02%.


CONCLUSIONS
The effectiveness of GnRH agonist treatment for endometriosis was not decreased by the addition of add-back continuous combined hormone replacement therapy. Bone mineral density of the lumbar spine was maintained and subjective side effects were diminished.
Franke
H R
HR
Department of Obstetrics and Gynecology, Medisch Spectrum Twente Hospital Group, Enschede, The Netherlands. hfranke@xs4all.nl
van de Weijer
P H
PH
Pennings
T M
TM
van der Mooren
M J
MJ
D000328:Adult; D015519:Bone Density; D004311:Double-Blind Method; D004715:Endometriosis / Q000188:drug therapy*; D004958:Estradiol / Q000097:blood; D004967:Estrogens / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D017273:Goserelin / Q000008:administration & dosage / Q000627:therapeutic use*; D020249:Hormone Replacement Therapy; D006801:Humans; D009426:Netherlands; D011372:Progestins / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D014463:Ultrasonography; D014599:Uterus / Q000000981:diagnostic imaging
D004967:Estrogens; D011372:Progestins; D017273:Goserelin; D004958:Estradiol; D005640:Follicle Stimulating Hormone