Clinical Trials Directory

Trials / Completed

CompletedNCT03890042

Dienogest for Treatment of Adenomyotic Uteri

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (actual)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGDienogest groupVISANNE 2MG Tablet once daily
DRUGGestodene-Ethinyl EstradiolGynera tablet once daily
RADIATIONUltrasoundultrasound assessment of uterine volume
OTHERvisual analogue scalevisual analogue scale for assessment of pain

Timeline

Start date
2019-03-01
Primary completion
2020-07-01
Completion
2020-08-01
First posted
2019-03-26
Last updated
2020-08-25

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03890042. Inclusion in this directory is not an endorsement.