search
Back to results

Dienogest for Treatment of Adenomyotic Uteri

Primary Purpose

Adenomyosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dienogest group
Gestodene-Ethinyl Estradiol
Ultrasound
visual analogue scale
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenomyosis

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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 .

Sites / Locations

  • Women Health Hospital - Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dienogest group

Gynera group

Arm Description

Outcomes

Primary Outcome Measures

Number of women who will improved from the pelvic pain measured by visual analogue scale

Secondary Outcome Measures

Uterine volume (cm 3 ) measure by ultrasound

Full Information

First Posted
March 23, 2019
Last Updated
August 22, 2020
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03890042
Brief Title
Dienogest for Treatment of Adenomyotic Uteri
Official Title
Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dienogest group
Arm Type
Active Comparator
Arm Title
Gynera group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dienogest group
Intervention Description
VISANNE 2MG Tablet once daily
Intervention Type
Drug
Intervention Name(s)
Gestodene-Ethinyl Estradiol
Intervention Description
Gynera tablet once daily
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
ultrasound assessment of uterine volume
Intervention Type
Other
Intervention Name(s)
visual analogue scale
Intervention Description
visual analogue scale for assessment of pain
Primary Outcome Measure Information:
Title
Number of women who will improved from the pelvic pain measured by visual analogue scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Uterine volume (cm 3 ) measure by ultrasound
Time Frame
6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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 .
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33454995
Citation
Hassanin AI, Youssef AA, Yousef AM, Ali MK. Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.
Results Reference
derived

Learn more about this trial

Dienogest for Treatment of Adenomyotic Uteri

We'll reach out to this number within 24 hrs