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

University of Oklahoma (OU)

Status: Withdrawn

Conditions: Endometrioma

Treatments: Drug: ferrous fumarate (placebo) tablets; Drug: Norethindrone acetate and ethinyl estradiol tablets, USP

Study type: Interventional

Funder types: Other

Identifiers

NCT00999479

Endometrioma

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Monophasic OCP

Experimental group

Description:

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

Treatment:

Drug: Norethindrone acetate and ethinyl estradiol tablets, USP

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: ferrous fumarate (placebo) tablets