Continuous Versus Cyclic Oral Contraceptives for Endometriosis

Phase 4

• Conditions: Dysmenorrhea; Dyspareunia; Pelvic Pain; Endometrioma
• Interventions: Drug: Oral contraceptives cyclic; Drug: Oral contraceptives continuous

• Registration Number: NCT02237131
• Lead Sponsor: University of Athens

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-03-22
• Study Start: 2014-04
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-09
• Last Update Submitted: 2014-09-09
• Study First Posted: 2014-09-11
• Last Update Posted: 2014-09-11
• Primary Completion: 2015-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria

Contraindications of use of oral contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral contraceptives continuous	Oral contraceptives cyclic	Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.
Oral contraceptives continuous	Oral contraceptives continuous	Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.
Oral contraceptives cyclic	Oral contraceptives cyclic	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.
Oral contraceptives cyclic	Oral contraceptives continuous	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.

Primary Outcome Measures

Name	Time	Method
Pelvic pain	6 months	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)

Secondary Outcome Measures

Name	Time	Method
recurrence rate for endometrioma	6 months	Physical and transvaginal sonographic examination

Trial Locations

Locations (1)

Aretaieion Hospital; 🇬🇷 Athens, Greece