Dienogest for Treatment of Adenomyotic Uteri

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ClinicalTrials.gov Identifier: NCT03890042

Recruitment Status : Recruiting

First Posted : March 26, 2019

Last Update Posted : March 26, 2019

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Mohammed Khairy Ali, Assiut University

Study Description

Brief Summary:

Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.

Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis

Condition or disease	Intervention/treatment	Phase
Adenomyosis	Drug: Dienogest group Drug: Gestodene-Ethinyl Estradiol Radiation: Ultrasound Other: visual analogue scale	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
Actual Study Start Date :	March 1, 2019
Estimated Primary Completion Date :	August 2019
Estimated Study Completion Date :	September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dienogest group	Drug: Dienogest group VISANNE 2MG Tablet once daily Radiation: Ultrasound ultrasound assessment of uterine volume Other: visual analogue scale visual analogue scale for assessment of pain
Active Comparator: Gynera group	Drug: Gestodene-Ethinyl Estradiol Gynera tablet once daily Radiation: Ultrasound ultrasound assessment of uterine volume Other: visual analogue scale visual analogue scale for assessment of pain

Outcome Measures

Primary Outcome Measures :

Number of women who will improved from the pelvic pain measured by visual analogue scale [ Time Frame: 6 months ]

Secondary Outcome Measures :

Uterine volume (cm 3 ) measure by ultrasound [ Time Frame: 6 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women aged 20-40 years
Women with ultrasonographic evidence of adenomyosis
Woman complains of vaginal bleeding or pelvic pain related to adenomyosis

Exclusion Criteria:

Women with a history of malignancy or histological evidence of endometrial hyperplasia
any adnexal abnormality on ultrasound
undiagnosed vaginal
contraindication to receive Vissane or gynera .

Contacts and Locations

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): NCT03890042

Locations

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Egypt
Women Health Hospital - Assiut university	Recruiting
Assiut, Egypt, 71111
Contact: Mohammed K ALi, MD +201005537951 m_khairy2001@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

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Responsible Party:	Mohammed Khairy Ali, Lecturer, Assiut University
ClinicalTrials.gov Identifier:	NCT03890042 History of Changes
Other Study ID Numbers:	DAD
First Posted:	March 26, 2019 Key Record Dates
Last Update Posted:	March 26, 2019
Last Verified:	March 2019

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Adenomyosis Uterine Diseases Genital Diseases, Female Dienogest Gestodene Femovan Estradiol Ethinyl Estradiol Nandrolone Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs	Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptive Agents, Male Contraceptives, Oral Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Androgens Anabolic Agents Contraceptives, Oral, Synthetic Progestins Contraceptives, Oral, Combined

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