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Dienogest for Treatment of Adenomyotic Uteri

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03890042
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : August 25, 2020
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 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
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dienogest

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

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

Secondary Outcome Measures :
  1. Uterine volume (cm 3 ) measure by ultrasound [ Time Frame: 6 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 .

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 identifier (NCT number): NCT03890042

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Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University Identifier: NCT03890042    
Other Study ID Numbers: DAD
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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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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Uterine Diseases
Ethinyl Estradiol
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
Contraceptives, Oral, Synthetic
Contraceptives, Oral, Combined