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

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ClinicalTrials.gov Identifier: NCT02599077
Recruitment Status : Suspended
First Posted : November 6, 2015
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
RICARDO RUEDA, Fundación Santa Fe de Bogota

Brief 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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: Dienogest Drug: Levonorgestrel Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas in Women With Diameters Smaller Than 4 Centimeters Thereof, at University Hospital Fundación Santa Fe de Bogota, Between the Years 2015-2017
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: Dienogest
the patient handling with 2 mg dienogest / day.
Drug: Dienogest
patients assigned to this treatment receive 2 milligrams per day
Other Name: visanne

Active Comparator: Levonorgestrel + ethinylestradiol
The patient handling with levonorgestrel + ethinylestradiol (0,10 mg - 0,02 )
Drug: Levonorgestrel
patients assigned to this treatment receive (0.10 mg levonorgestrel + ethinyl estradiol - 0.02 milligrams daily)
Other Name: diane




Primary Outcome Measures :
  1. the change from baseline in the size of the endometriomas, as determined by the diagnostic tool ultrasound, subsequent to drug treatment [ Time Frame: one year ]
    The change from baseline in the size of the endometriomas, as determined by the diagnostic tool of ultrasound in a year of contraceptive treatment



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women Of childbearing age (this period), without desire for fertility, without treatment for endometriosis in the past three months, with ultrasound diagnosis of endometrioma (unilateral or bilateral) minor diameter to 4 centimeters. Those who do not go to surgical procedure and who choose or who are instructed to follow a medical management. No contraindications to oral contraceptive use, rating and eligibility criteria of WHO 1 (no restriction can be used in all circumstances) or 2 (the advantages of using the method generally outweigh the risks, usually can be used) . And who they entered the University Hospital Fundación Santa Fe de Bogota.

Exclusion Criteria:

Intercurrent cardiovascular-disease or a history of it (arterial thrombosis or current or previous venous thromboembolism, thrombophilic genetic disease), smoking, obesity, kidney failure, SLE, diagnosed or suspected autoimmune diseases and hypertension.

If you have a history of migraine accompanied by eg visual symptoms, slurred speech or weakness or numbness in any part of the body.

If you have diabetes mellitus with blood vessels. If you have or have had pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood.

If you have jaundice (yellowing of the skin) or severe liver disease. If you have or have had a cancer that may grow under the influence of sex hormones (eg of the breast or genitals).

If you have or have had a liver tumor, benign or malignant. If you have any unexplained vaginal bleeding. If you are pregnant or think you might be. If you are hypersensitive (allergic) to ethinyl estradiol, levonorgestrel, dienogest or any other part.


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): NCT02599077


Locations
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Colombia
Fundación Santa Fe de Bogota
Bogota, Cundinamarca, Colombia, 110111
Sponsors and Collaborators
Fundación Santa Fe de Bogota
Investigators
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Study Chair: Lina restrepo Fundación Santa Fe de Bogota

Publications of Results:
Other Publications:
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Responsible Party: RICARDO RUEDA, gynecologist, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT02599077     History of Changes
Other Study ID Numbers: FSantafeBogota
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Keywords provided by RICARDO RUEDA, Fundación Santa Fe de Bogota:
oral contraceptives
endometrioma
dienogest
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female
Dienogest
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Ethinyl Estradiol
Nandrolone
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Male
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Anabolic Agents