Dienogest for Treatment of Adenomyotic Uteri

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03890042

Enrollment

100

Registered

2019-03-26

Start date

2019-03-01

Completion date

2020-08-01

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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 .

Design outcomes

Primary

Measure	Time frame
Number of women who will improved from the pelvic pain measured by visual analogue scale	6 months

Secondary

Measure	Time frame
Uterine volume (cm 3 ) measure by ultrasound	6 month

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026