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

NCT02599077 | Suspended Phase 2 DMC

• 1 other identifier: FSantafeBogota
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

oral contraceptives; endometrioma; dienogest

Outcome Measures

Primary Outcomes (1)

• the change from baseline in the size of the endometriomas, as determined by the diagnostic tool ultrasound, subsequent to drug treatment

  The change from baseline in the size of the endometriomas, as determined by the diagnostic tool of ultrasound in a year of contraceptive treatment

  one year

Study Arms (2)

Dienogest

EXPERIMENTAL

the patient handling with 2 mg dienogest / day.

Drug: Dienogest

Levonorgestrel + ethinylestradiol

ACTIVE COMPARATOR

The patient handling with levonorgestrel + ethinylestradiol (0,10 mg - 0,02 )

Drug: Levonorgestrel

Interventions

Dienogest DRUG

patients assigned to this treatment receive 2 milligrams per day

Also known as: visanne

Dienogest

Levonorgestrel DRUG

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

Also known as: diane

Levonorgestrel + ethinylestradiol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Fundación Santa Fe de Bogota

Bogota, Cundinamarca, 110111, Colombia

Location

Related Publications (7)

• Practice Committee of the American Society for Reproductive Medicine. Endometriosis and infertility: a committee opinion. Fertil Steril. 2012 Sep;98(3):591-8. doi: 10.1016/j.fertnstert.2012.05.031. Epub 2012 Jun 15.

  PMID: 22704630 BACKGROUND

• Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30.

  PMID: 21718982 BACKGROUND

• Eskenazi B, Warner ML. Epidemiology of endometriosis. Obstet Gynecol Clin North Am. 1997 Jun;24(2):235-58. doi: 10.1016/s0889-8545(05)70302-8.

  PMID: 9163765 BACKGROUND

• Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012 Jul 20.

  PMID: 22819144 BACKGROUND

• Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010 Jun 24;362(25):2389-98. doi: 10.1056/NEJMcp1000274.

  PMID: 20573927 BACKGROUND

• Ruan X, Seeger H, Mueck AO. The pharmacology of dienogest. Maturitas. 2012 Apr;71(4):337-44. doi: 10.1016/j.maturitas.2012.01.018. Epub 2012 Feb 24.

  PMID: 22364708 BACKGROUND

• Harada T, Momoeda M, Taketani Y, Aso T, Fukunaga M, Hagino H, Terakawa N. Dienogest is as effective as intranasal buserelin acetate for the relief of pain symptoms associated with endometriosis--a randomized, double-blind, multicenter, controlled trial. Fertil Steril. 2009 Mar;91(3):675-81. doi: 10.1016/j.fertnstert.2007.12.080. Epub 2008 Jul 23.

  PMID: 18653184 RESULT

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest; Levonorgestrel; Cyproterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids, Chlorinated

Study Officials

• Lina restrepo

  Fundación Santa Fe de Bogota

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: gynecologist

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: November 6, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

CO (1)