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Trial record 66 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

Continuous Versus Cyclic Oral Contraceptives for Endometriosis

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ClinicalTrials.gov Identifier: NCT02237131
Recruitment Status : Unknown
Verified September 2014 by Nikos Vlahos, University of Athens.
Recruitment status was:  Recruiting
First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Nikos Vlahos, University of Athens

Tracking Information
First Submitted Date  ICMJE March 22, 2014
First Posted Date  ICMJE September 11, 2014
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
Pelvic pain [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2014)
recurrence rate for endometrioma [ Time Frame: 6 months ]
Physical and transvaginal sonographic examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 9, 2014)
dysmenorrhea [ Time Frame: 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Continuous Versus Cyclic Oral Contraceptives for Endometriosis
Official Title  ICMJE Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Dysmenorrhea
  • Pelvic Pain
  • Dyspareunia
  • Endometrioma
Intervention  ICMJE
  • 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 Name: 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 Name: Yasmin
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Oral contraceptives cyclic
    • Drug: Oral contraceptives continuous
  • 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.
    Interventions:
    • Drug: Oral contraceptives cyclic
    • Drug: Oral contraceptives continuous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 9, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria:

Contraindications of use of oral contraceptives

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02237131
Other Study ID Numbers  ICMJE NV04042013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nikos Vlahos, University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Athens
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP