Continuous Versus Cyclic Oral Contraceptives for Endometriosis

Sponsor

University of Athens (Other)

Overall Status

Unknown status

CT.gov ID

NCT02237131

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea Pelvic Pain Dyspareunia Endometrioma	Drug: Oral contraceptives cyclic Drug: Oral contraceptives continuous	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Apr 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Oral contraceptives cyclic 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. Other Names: Yasmin. Drug: Oral contraceptives continuous Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion. Other Names: Yasmin
Active Comparator: 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.	Drug: Oral contraceptives cyclic 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. Other Names: Yasmin. Drug: Oral contraceptives continuous Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion. Other Names: Yasmin

Arm

Intervention/Treatment

Experimental: 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.

Drug: Oral contraceptives cyclic

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.

Other Names:

Yasmin.

Drug: Oral contraceptives continuous

Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.

Other Names:

Yasmin

Active Comparator: 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.

Drug: Oral contraceptives cyclic

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.

Other Names:

Yasmin.

Drug: Oral contraceptives continuous

Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.

Other Names:

Yasmin

Outcome Measures

Primary Outcome Measures

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

recurrence rate for endometrioma [6 months]
Physical and transvaginal sonographic examination

Other Outcome Measures

dysmenorrhea [6 months]
In each visit patients were asked to complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of dysmenorrhea (scoring of dysmenorrhea)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria:

Contraindications of use of oral contraceptives

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aretaieion Hospital	Athens		Greece

Sponsors and Collaborators

University of Athens

Investigators

Study Chair: Nikos Vlahos, AssProfessor, University of Athens, 2nd Department of Obstetrics and Gynecology
Principal Investigator: Olga Triantafyllidou, MD, University of Athens, 2nd Department of Obstetrics and Gynecology