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CompletedNCT03890042Updated Aug 25, 2020

Dienogest for Treatment of Adenomyotic Uteri

An interventional study of Dienogest group and Gestodene-Ethinyl Estradiol in Adenomyosis, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-08-25.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
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Study 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

02

Conditions studied

  • Adenomyosis

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03

In context

Adenomyosis

135 studies on the registry are indexed under Adenomyosis; 50 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 73 interventional studies indexed under Adenomyosis.

Browse Adenomyosis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
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

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 .
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Dienogest group

    Drug: Dienogest group · Radiation: Ultrasound · Other: visual analogue scale

  • Active comparator
    Gynera group

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

Interventions

  • DrugDienogest group

    VISANNE 2MG Tablet once daily

  • DrugGestodene-Ethinyl Estradiol

    Gynera tablet once daily

  • RadiationUltrasound

    ultrasound assessment of uterine volume

  • Othervisual analogue scale

    visual analogue scale for assessment of pain

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What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Uterine volume (cm 3 ) measure by ultrasound

    Time frame: 6 month

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Study locations

1 site
  • Women Health Hospital - Assiut university
    Assiut, 71111, Egypt
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References and documents

Publications

  • 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. PubMed 33454995 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03890042
Lead sponsor
Assiut University
Responsible party
Mohammed Khairy Ali (Lecturer, Assiut University) — Principal investigator
First posted
Mar 26, 2019
Start date
Mar 1, 2019
Primary completion
Jul 1, 2020
Completion
Aug 1, 2020
Last update
Aug 25, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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