- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599077
Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Problem and Justification:
Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity, which induces a chronic inflammatory response.
It is a common problem that affects about 6-10% of women of reproductive age, 50-60% of women and adolescents with pelvic pain and nearly 50% of women with infertility. it is characterized by abdominal pain, back pain, pain during sex, dysfunctional uterine bleeding and infertility. Being a common condition among women of childbearing age, which often goes undiagnosed for many years. This delay in diagnosis is due to the variability of symptoms and the lack of tools for accurate diagnosis available for primary care, which is a major burden on the quality of life of patients symptomatic.
The diagnosis of endometriosis should start with clinical history and physical examination and transvaginal ultrasound has proven useful in the diagnosis of ovarian endometriomas and its differential diagnosis with other ovarian masses.
Histologically the lesions identified in endometriosis resemble endometrial tissue in places outside the endometrium, which proliferates in response to hormonal changes that occur with menstruation, causing increased pain and bleeding.
Pharmacological agents are preferred as first-line treatment for managing the symptoms. Among these, oral contraceptives are used to treat symptoms of menorrhagia and dysmenorrhoea associated with endometriosis, affecting the endometrial lining by decreasing the proliferation of endometrial tissue during the menstrual cycle, to shorten the number of days in which endometrial tissue appears, reducing the amount and consistency of bleeding.
Another drug that is used to manage this condition is the Dienogest, which has proven superior to treatment with placebo and the effect is comparable to that of other drugs used in the management of endometriosis, as progestins or GnRH analogues.
All drug treatments for endometriosis are effective in reducing the size and number of lesions, and are not intended to cure the disease or eliminate the injury of the peritoneal cavity. Another management option is surgery, which should be reserved for specific cases or those patients who do not respond to drug treatment.
Endometriosis is a disease that imposes a severe financial burden on society, and a physical and emotional toll on people who have it. Therefore it is important to understand, and education by medical staff against this disease. According to the statistics service approximately 200 women a year are treated in reproductive age of which on average 50 are endometriomas and since there is no clear scientific evidence on the impact of combined oral contraceptives compared with using Dienogest, the objective of this study is to determine the impact of Dienogest to 2 mg / day compared with combined oral contraceptives (levonorgestrel + ethinyl estradiol) in reducing the size of the endometriomas diagnosed by transvaginal ultrasound in women with diameters smaller than 4 centimeters thereof, in the Hospital Universitario Fundación Santa Fe de Bogota.
Goals:
General: Determine the impact of Dienogest to 2 mg / day compared with combined oral contraceptives (levonorgestrel + ethinyl estradiol 0.10 mg - 0.02 mg / day) in the treatment of endometriomas diagnosed by transvaginal ultrasound in women with smaller diameters 4 centimeters thereof, at University Hospital Fundación Santa Fe de Bogota.
Specific:
- Determine Decreasing the size of endometriomas Dienogest using as medical treatment for endometriosis.
- Determine Decreased endometriomas size using a combined oral contraceptive as medical treatment for endometriosis.
- Determine Through ultrasound scanning diagnostic tool as the impact of the reduction in size of endometriomas.
- Compare The effect of the Dienogest vs the combined oral contraceptive in time. Methodology Type of study Experimental study single-blind randomized clinical trial by the observer. Universe Endometriomas of patients with diameters smaller than 4 centimeters diagnosed by transvaginal ultrasound in patients presenting to the Santa Fe de Bogota Foundation between 2015 and 2016.
Sample size
To analyze cases of endometriomas in which medical management vs Dienogest be used with oral contraceptives, the sample size is calculated using the estimated sample size with a comparison of proportions between 2 samples with the following information:
N: 200 Proportion: 1.6%, and the estimated prevalence of endometriosis is 8% and 20% of those with endometriomas.
Confidence level: 95% Z2: 1.96 Alpha error 5% No: 22 Estimated loss: 10%
Sample required:
N1: 25 N2: 25
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110111
- Fundacion Santa Fe de Bogota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dienogest
the patient handling with 2 mg dienogest / day.
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patients assigned to this treatment receive 2 milligrams per day
Other Names:
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Active Comparator: Levonorgestrel + ethinylestradiol
The patient handling with levonorgestrel + ethinylestradiol (0,10 mg - 0,02 )
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patients assigned to this treatment receive (0.10 mg levonorgestrel + ethinyl estradiol - 0.02 milligrams daily)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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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one year
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Lina restrepo, Fundacion Santa Fe de Bogota
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Giudice LC. Clinical practice. Endometriosis. N Engl J Med. 2010 Jun 24;362(25):2389-98. doi: 10.1056/NEJMcp1000274.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endometriosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Levonorgestrel
- Dienogest
Other Study ID Numbers
- FSantafeBogota
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