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

This study has been withdrawn prior to enrollment.
(Poor enrollment)
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00999479
First received: October 20, 2009
Last updated: December 9, 2013
Last verified: December 2013

October 20, 2009
December 9, 2013
October 2009
October 2011   (final data collection date for primary outcome measure)
To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation. [ Time Frame: October 2011 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999479 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Endometrioma
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00999479
Endometrioma
Yes
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Katie M Smith, M.D. University of Oklahoma
University of Oklahoma
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP