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Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas

NCT02599077 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-22

No results posted yet for this study

Summary

Project Summary Endometriosis is a disease with a high prevalence that primarily affects women of childbearing age. This condition brings an important physical and emotional burden on sufferers and this is why it requires proper and timely medical management. At present there are several first-line drugs available for the management of symptoms and disease control. In the world literature we have reported several studies that demonstrate the effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH analogues and danazol. Within the available scientific evidence it has been extensively described the benefits of the new progestins Dienogest, demonstrating a favorable safety profile and efficacy along with a significant reduction of the symptoms of the disease by its anti-inflammatory, and antiproliferative antiagiogénicas in the endometrial tissue . However, although the therapeutic properties of this drug are known, studies are needed to compare its effectiveness with the effectiveness of other therapeutic agents as oral contraceptives. That is why the main objective of this study is to evaluate the impact of Dienogest to 2 mg / day compared with a combined oral contraceptive (levonorgestrel + ethinyl estradiol) in the size of the endometriomas diagnosed by transvaginal ultrasonography in 50 women having diameters less than 4 centimeters of the same, which medical management will be given for one year at the University Hospital Fundación Santa Fe de Bogota. The study was conducted by a clinical trial, randomized, single-blind by the observer. The results will be analyzed and the findings in the study will serve as a tool to define new therapeutic conduct in the management of endometriosis.

Conditions

  • Endometriosis

Interventions

DRUG

Dienogest

patients assigned to this treatment receive 2 milligrams per day

DRUG

Levonorgestrel

patients assigned to this treatment receive (0.10 mg levonorgestrel + ethinyl estradiol - 0.02 milligrams daily)

Sponsors & Collaborators

  • Fundación Santa Fe de Bogota

    lead OTHER

Principal Investigators

  • Lina restrepo · Fundación Santa Fe de Bogota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2018-11-30

Countries

  • Colombia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599077 on ClinicalTrials.gov