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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00999479
Other study ID # Endometrioma
Secondary ID
Status Withdrawn
Phase N/A
First received October 20, 2009
Last updated December 9, 2013
Start date October 2009
Est. completion date October 2011

Study information

Verified date December 2013
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


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.
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.

Locations

Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation. October 2011 No
Secondary 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. October 2011 No
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