Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
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|ClinicalTrials.gov Identifier: NCT00999479|
Recruitment Status : Withdrawn (Poor enrollment)
First Posted : October 21, 2009
Last Update Posted : December 10, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Endometrioma||Drug: Norethindrone acetate and ethinyl estradiol tablets, USP Drug: ferrous fumarate (placebo) tablets||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
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
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.
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.
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.
- To determine whether or not continuous combined oral contraceptive pills decrease the risk of recurrent endometrioma formation. [ Time Frame: October 2011 ]
- 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 ]
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|Ages Eligible for Study:||18 Years to 35 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- Patients with a diagnosis of ovarian endometriotic cyst that has been surgically excited.
- Current desire to achieve pregnancy or other contraindication to combined oral contraceptive pills.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999479
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Katie M Smith, M.D.||University of Oklahoma|
|Responsible Party:||University of Oklahoma|
|Other Study ID Numbers:||
|First Posted:||October 21, 2009 Key Record Dates|
|Last Update Posted:||December 10, 2013|
|Last Verified:||December 2013|
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral, Synthetic