DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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Status: Withdrawn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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017