Dienogest for Treatment of Adenomyotic Uteri

August 22, 2020 updated by: Mohammed Khairy Ali, Assiut University

Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Radiation: Ultrasound
ultrasound assessment of uterine volume
Other: visual analogue scale
visual analogue scale for assessment of pain
Drug: Gestodene-Ethinyl Estradiol
Gynera tablet once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Uterine volume (cm 3 ) measure by ultrasound
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

March 23, 2019

First Submitted That Met QC Criteria

March 23, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 22, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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