NCT02237131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

March 22, 2014

Last Update Submit

September 9, 2014

Conditions

DysmenorrheaPelvic PainDyspareuniaEndometrioma

Keywords

EndometriosisOral contraceptivesLaparoscopy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • recurrence rate for endometrioma

    6 months

Other Outcomes (1)

  • dysmenorrhea

    6 months

Study Arms (2)

Oral contraceptives cyclic

EXPERIMENTAL

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 cyclicDrug: Oral contraceptives continuous

Oral contraceptives continuous

ACTIVE COMPARATOR

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 cyclicDrug: Oral contraceptives continuous

Interventions

Oral contraceptives cyclicDRUG

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.

Also known as: Yasmin.
Oral contraceptives continuousOral contraceptives cyclic
Oral contraceptives continuousDRUG

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

Also known as: Yasmin
Oral contraceptives continuousOral contraceptives cyclic

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

You may not qualify if:

  • Contraindications of use of oral contraceptives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieion Hospital

Athens, Athens, Greece

RECRUITING

MeSH Terms

Conditions

DysmenorrheaPelvic PainDyspareuniaEndometriosis

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Nikos Vlahos, AssProfessor

    University of Athens, 2nd Department of Obstetrics and Gynecology

    STUDY CHAIR

  • Olga Triantafyllidou, MD

    University of Athens, 2nd Department of Obstetrics and Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga B Triantafyllidou, M.D, Msc

CONTACT

+306944963506triantafyllidouolga@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics

Study Record Dates

First Submitted

March 22, 2014

First Posted

September 11, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

GR(1)