Continuous Versus Cyclic Oral Contraceptives for Endometriosis

NCT ID: NCT02237131

Last Updated: 2014-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

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.

Conditions

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Dysmenorrhea Pelvic Pain Dyspareunia Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Oral contraceptives cyclic

Intervention Type DRUG

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

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Oral contraceptives cyclic

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Yasmin. Yasmin

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Nikos Vlahos

M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikos Vlahos, AssProfessor

Role: STUDY_CHAIR

University of Athens, 2nd Department of Obstetrics and Gynecology

Olga Triantafyllidou, MD

Role: PRINCIPAL_INVESTIGATOR

University of Athens, 2nd Department of Obstetrics and Gynecology

Locations

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Aretaieion Hospital

Athens, Athens, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Olga B Triantafyllidou, M.D, Msc

Role: CONTACT

+306944963506

Facility Contacts

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Olga B Triantafyllidou, M.D, Msc

Role: primary

+306944963506

Other Identifiers

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NV04042013

Identifier Type: -

Identifier Source: org_study_id

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