Clinical and radiological effects of Dienogest on patients with symptomatic uterine myoma versus placebo: A randomized control trial

A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy of Dienogest (2 mg/day) on Leiomyoma Volume and Symptom Burden in Women with Symptomatic Uterine Myomas

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202512770428919

Enrollment

Registered

2025-12-15

Start date

2026-01-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

fibroid

Interventions

placebo

Deinogest

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age 20-45 years 2. Women with symptomatic uterine leiomyoma (sub-mucous, sub-serous, or intramural), confirmed by transvaginal sonography, including those with multiple myomas, with specific symptom thresholds: Heavy menstrual bleeding (baseline PBLAC score = 150) or dysmenorrhea (baseline VAS score = 4), and for submucous myomas only FIGO types 1–2 (intracavitary <50%) and =5 cm in diameter 3. Uterine fibroids appearing as concentric, solid, hypoechoic masses on ultrasound

Exclusion criteria

Exclusion criteria: 1. Pregnant (confirmed by negative serum ß-hCG test at enrollment, with repeat testing at 3 and 6 months) or menopausal women 2. History of malignancies, metabolic, hematologic, cardiac, thromboembolic, diabetic, renal, or hepatic diseases 3. Hormonal drug use in the past three months 4. Participants unwilling to use non-hormonal contraception (barrier methods) throughout the trial and for 4 weeks after discontinuation

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in leiomyoma volume after 6 months, measured via transvaginal ultrasound using the prolate ellipsoid formula (p/6 × length × width × anterior-posterior diameter), with the largest fibroid selected as the target lesion in cases of multiple myomas.	—

Secondary

Measure	Time frame
Dysmenorrhea: Measured using the Visual Analog Scale (VAS) at baseline and monthly over the 6-month treatment period to track pain severity changes. ;Uterine Volume: Assessed via transvaginal ultrasound using the prolate ellipsoid formula at baseline and after 6 months of therapy to evaluate overall uterine size reduction. ;Heavy Menstrual Bleeding (HMB): Quantified using the Pictorial Blood Loss Assessment Chart (PBLAC) and hemoglobin levels (via venous blood samples) at baseline and after 6 months to objectively measure bleeding volume and anemia improvement.	—

Measure

Time frame

Dysmenorrhea: Measured using the Visual Analog Scale (VAS) at baseline and monthly over the 6-month treatment period to track pain severity changes. ;Uterine Volume: Assessed via transvaginal ultrasound using the prolate ellipsoid formula at baseline and after 6 months of therapy to evaluate overall uterine size reduction. ;Heavy Menstrual Bleeding (HMB): Quantified using the Pictorial Blood Loss Assessment Chart (PBLAC) and hemoglobin levels (via venous blood samples) at baseline and after 6 months to objectively measure bleeding volume and anemia improvement.

—

Countries

Egypt

Contacts

Public Contactahmed abdelhamid

professor

ahmedgyna@yahoo.com00966564820942

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026