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Dienogest for Treatment of Adenomyotic Uteri

A

Assiut University

Status

Completed

Conditions

Adenomyosis

Treatments

Radiation: Ultrasound
Drug: Gestodene-Ethinyl Estradiol
Drug: Dienogest group
Other: visual analogue scale

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

100 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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 .

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Dienogest group
Active Comparator group
Treatment:
Radiation: Ultrasound
Drug: Dienogest group
Other: visual analogue scale
Gynera group
Active Comparator group
Treatment:
Radiation: Ultrasound
Other: visual analogue scale
Drug: Gestodene-Ethinyl Estradiol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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