Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas
Status:
Suspended
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
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.