Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Information source: University of Oklahoma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrioma
Intervention: Norethindrone acetate and ethinyl estradiol tablets, USP (Drug); ferrous fumarate (placebo) tablets (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: University of Oklahoma Official(s) and/or principal investigator(s): Katie M Smith, M.D., Principal Investigator, Affiliation: University of Oklahoma
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.
Clinical Details
Official title: Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation.
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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.
Locations and Contacts
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Additional Information
Starting date: October 2009
Last updated: December 9, 2013
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