Dienogest for Treatment of Adenomyotic Uteri

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Adenomyosis
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Brief Title

Dienogest for Treatment of Adenomyotic Uteri

Official Title

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

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

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Uterine volume (cm 3 ) measure by ultrasound

Condition

Adenomyosis

Intervention

Dienogest group

Study Arms / Comparison Groups

 Dienogest group
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100

Start Date

March 1, 2019

Completion Date

August 1, 2020

Primary Completion Date

July 1, 2020

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 .

Gender

Female

Ages

20 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT03890042

Organization ID

DAD

Responsible Party

Principal Investigator

Study Sponsor

Assiut University

Study Sponsor

, ,

Verification Date

August 2020