Oral estroprogestins after laparoscopic surgery to excise endometriomas: continuous or cyclic administration? Results of a multicenter randomized study.
OBJECTIVE
To evaluate continuous (CON) compared with cyclic (CYC) administration of combined oral estroprogestins for 6 months after laparoscopic excision of ovarian endometriomas associated with pain.


METHODS
Multicenter, prospective, randomized trial (Canadian Task Force classification I).


METHODS
Tertiary care university hospitals.


METHODS
Fifty-seven women aged 18 to 40 years with ovarian endometriomas associated with moderate to severe pelvic pain who underwent laparoscopic excision of the disease.


METHODS
Patients were randomized to receive postoperative estroprogestins for 6 months, administered as either a CON or CYC regimen.


RESULTS
At 3, 6, 12, and 24 months postoperatively, patients were evaluated for recurrence of endometriomas (defined as cysts >3 cm in greatest diameter) using ultrasonography, for recurrence of pain using a visual analog scale, and for patient satisfaction. After a minimum follow-up of 12 months (mean, 22 months), at intent-to-treat analysis, no endometrioma recurrence was observed in the CON group, whereas there was recurrence in 1 patient (4%) in the CYC group. Pain recurred in 5 and 9 patients, respectively (17% vs 32%; p = .23). Compared with pretreatment values, pain scores improved in both groups, with no significant difference between the 2 groups. Most patients in both groups were either satisfied or very satisfied, with no significant difference between treatment groups. However, compared with the CYC group, significantly more patients in the CON group experienced moderate to severe adverse effects, and therapy was discontinued (41% vs 14%; p = .03).


CONCLUSIONS
Although both regimens were equally effective insofar as postoperative pain and recurrence of endometrioma, when compared with the CYC regimen, the CON regimen seems to be associated with significantly more adverse effects and discontinuation rates.
Department of Obstetrics and Gynecology, Campus Bio-Medico University, Rome, Italy. l.muzii@unicampus.it
Ludovico
L
Muzii
Francesco
F
Maneschi
Riccardo
R
Marana
Maria Grazia
MG
Porpora
Errico
E
Zupi
Filippo
F
Bellati
Roberto
R
Angioli
Pierluigi
P
Benedetti Panici
D000293:Adolescent; D000328:Adult; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004715:Endometriosis / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D004997:Ethinyl Estradiol / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D013509:Gynecologic Surgical Procedures; D006801:Humans; D010535:Laparoscopy; D009652:Norpregnenes / Q000008:administration & dosage* / Q000627:therapeutic use; D010049:Ovarian Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D010146:Pain / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D010147:Pain Measurement; D017060:Patient Satisfaction; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome; D014463:Ultrasonography
D004338:Drug Combinations; D009652:Norpregnenes; C494367:estroprogestin; D004997:Ethinyl Estradiol