Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation

• ClinicalTrials.gov Identifier: NCT00999479
• Recruitment Status: Withdrawn
• First Posted: October 21, 2009
• Last Update Posted: December 10, 2013
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: October 20, 2009
• First Posted Date: October 21, 2009
• Last Update Posted Date: December 10, 2013
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2009): To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation. [ Time Frame: October 2011 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 20, 2009): 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. [ Time Frame: October 2011 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Endometrioma

Intervention

• Drug: Norethindrone acetate and ethinyl estradiol tablets, USP

  Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets.

  Each white tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol. Each white tablet also contains the following inactive ingredients: acacia, lactose, magnesium stearate, starch, confectioner's sugar, and talc.

• Drug: ferrous fumarate (placebo) tablets
  Loestrin® 24 Fe provides a dosage regimen consisting of 24 white progestogen-estrogen contraceptive tablets and 4 brown ferrous fumarate (placebo) tablets. Each brown tablet contains ferrous fumarate, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and compressible sugar. The ferrous fumarate tablets do not serve any therapeutic purpose.

Study Arms

• Experimental: Monophasic OCP
  Patients randomized to this study arm will receive combined oral contraceptive pills. Patients will follow up at 2, 6, 12, 18 and 24 months. On follow up visits pts will have clinical assessment with vaginal and rectal examinations and with transvaginal ultrasonography. As a measure of compliance, patients will return their empty pill packages
  Intervention: Drug: Norethindrone acetate and ethinyl estradiol tablets, USP
• Placebo Comparator: Placebo
  Patients assigned to this arm will use non-hormonal, barrier contraceptives to prevent pregnancy.Patients will follow up at 2, 6, 12, 18 and 24 months. On follow up visits pts will have clinical assessment with vaginal and rectal examinations and with transvaginal ultrasonography. As a measure of compliance, patients will return their empty pill packages.
  Intervention: Drug: ferrous fumarate (placebo) tablets

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 9, 2013): 0
• Original Estimated Enrollment (submitted: October 20, 2009): 70
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00999479
• Other Study ID Numbers: Endometrioma
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Oklahoma
• Original Responsible Party: Katie M. Smith, M.D., University of Oklahoma Health Sciences Center/Ob/Gyn
• Current Study Sponsor: University of Oklahoma
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Katie M Smith, M.D.; University of Oklahoma

• PRS Account: University of Oklahoma
• Verification Date: December 2013