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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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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 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

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 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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. recurrence rate for endometrioma [ Time Frame: 6 months ]
    Physical and transvaginal sonographic examination


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery

Exclusion Criteria:

Contraindications of use of oral contraceptives


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237131


Contacts
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Contact: Olga B Triantafyllidou, M.D, Msc +306944963506 triantafyllidouolga@yahoo.com

Locations
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Greece
Aretaieion Hospital Recruiting
Athens, Greece
Contact: Olga B Triantafyllidou, M.D, Msc    +306944963506    triantafyllidouolga@yahoo.com   
Principal Investigator: Nikos Vlahos, AssProfessor         
Sponsors and Collaborators
University of Athens
Investigators
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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

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Responsible Party: Nikos Vlahos, M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics, University of Athens
ClinicalTrials.gov Identifier: NCT02237131     History of Changes
Other Study ID Numbers: NV04042013
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014
Keywords provided by Nikos Vlahos, University of Athens:
Endometriosis
Oral contraceptives
Laparoscopy
Additional relevant MeSH terms:
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Drospirenone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Drospirenone and ethinyl estradiol combination
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Endometriosis
Dyspareunia
Pelvic Pain
Dysmenorrhea
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Contraceptive Agents
Contraceptives, Oral
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists