Continuous Versus Cyclic Oral Contraceptives for Endometriosis

Study Overview
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Brief Summary
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To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.

Detailed Description
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Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.

Official Title
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Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis

Conditions
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Dysmenorrhea, Pelvic Pain, Dyspareunia, Endometrioma

Intervention / Treatment
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* Drug: Oral contraceptives cyclic
* Drug: Oral contraceptives continuous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery Exclusion Criteria: Contraindications of use of oral contraceptives

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral contraceptives cyclic<br>Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial. | Drug: Oral contraceptives cyclic<br>* tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.<br>* Other names: Yasmin.;Drug: Oral contraceptives continuous<br>* Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.<br>* Other names: Yasmin;|
| Active Comparator: Oral contraceptives continuous<br>Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial. | Drug: Oral contraceptives cyclic<br>* tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.<br>* Other names: Yasmin.;Drug: Oral contraceptives continuous<br>* Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.<br>* Other names: Yasmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic pain | In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate for endometrioma | Physical and transvaginal sonographic examination | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Oral contraceptives, Laparoscopy