Dienogest for Treatment of Adenomyotic Uteri

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis

NCT03654144

Adenomyosis

UNKNOWN PHASE4

Ttt of Adenomyosis

NCT06719934

Adenomyosis

NOT_YET_RECRUITING PHASE1

Adenomyosis and ART

NCT05937490

Adenomyosis

UNKNOWN PHASE4

Levonorgestrel Intrauterine System and Adenomyosis

NCT03104309

Adenomyosis

COMPLETED NA

Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma

NCT03789123

Ovarian Reserve

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenomyosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dienogest group

Group Type ACTIVE_COMPARATOR

Dienogest group

Intervention Type DRUG

VISANNE 2MG Tablet once daily

Ultrasound

Intervention Type RADIATION

ultrasound assessment of uterine volume

visual analogue scale

Intervention Type OTHER

visual analogue scale for assessment of pain

Gynera group

Group Type ACTIVE_COMPARATOR

Gestodene-Ethinyl Estradiol

Intervention Type DRUG

Gynera tablet once daily

Ultrasound

Intervention Type RADIATION

ultrasound assessment of uterine volume

visual analogue scale

Intervention Type OTHER

visual analogue scale for assessment of pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dienogest group

VISANNE 2MG Tablet once daily

Intervention Type DRUG

Gestodene-Ethinyl Estradiol

Gynera tablet once daily

Intervention Type DRUG

Ultrasound

ultrasound assessment of uterine volume

Intervention Type RADIATION

visual analogue scale

visual analogue scale for assessment of pain

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 .

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No