Clinical trial NCT00999479: Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Official title: Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endometrioma
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether or not continuous combined oral contraceptive pills (COCP's) decrease the risk of recurrent endometrioma formation. The investigators' hypothesis is that patients who have endometriomas surgically removed and then are started on COCP's will have a decreased incidence of recurrent endometrioma formation. The investigators' research protocol is designed to show a statistically significant decreased incidence of endometrioma formation in the hopes that physicians will use COCP's in patients they have removed an endometrioma in who do not desire immediate fertility. Long term, the investigators hope to establish a standard of care that COCP's be used postoperatively in appropriate candidates to decrease the chance of recurrent endometrioma formation.

Detailed description: We plan to identify patients planning to undergo conservative surgery for endometrioma at the University of Oklahoma private practice OB/GYN clinic and at the University of Oklahoma Resident Women's clinic. After clear and appropriate consent and discussion regarding options, we plan to randomize patients to monophasic OCPs vs. placebo following surgery. We plan to enroll 35 patients in each arm and follow them for 24 months following the surgery. Surveillance with pelvic exam and transvaginal ultrasonography will occur at 2, 6 and 12 months. The patients surgery will be done prior to enrolling in our study. We will use information from their surgery only to confirm the diagnosis of endometrioma. The only procedure the subjects will undergo during the protocol are periodic transvaginal ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of ovarian endometriotic cyst that has been surgically excited.

Exclusion Criteria:

* Current desire to achieve pregnancy or other contraindication to combined oral contraceptive pills.

Primary outcomes:
measure: To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation.
timeFrame: October 2011
Secondary outcomes:
measure: Long term, we hope to establish a standard of care that COCPs be used postoperatively in appropriate candidates to decrease the chance of recurrent endometrioma formation.
timeFrame: October 2011
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Katie M Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References: