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NCT02237131 Clinical Trial

Continuous Versus Cyclic Oral Contraceptives for Endometriosis

Pelvic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02237131
Other study ID # NV04042013
Secondary ID
Status Recruiting
Phase Phase 4
First received March 22, 2014
Last updated September 9, 2014
Start date April 2014
Est. completion date December 2015

Study information
Verified date September 2014
Source University of Athens
Contact Olga B Triantafyllidou, M.D, Msc
Phone +306944963506
Email triantafyllidouolga@yahoo.com
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria:

Contraindications of use of oral contraceptives

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Greece Aretaieion Hospital Athens

Sponsors (1)
Lead Sponsor Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Other dysmenorrhea 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) 6 months Yes
Primary 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 Yes
Secondary recurrence rate for endometrioma Physical and transvaginal sonographic examination 6 months Yes
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