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Evaluation of the treatment of Uterine Endometriosis with three types of hormones: Dienogest pill, Etonogestrel implant and System releasing Levonorgestrel

Evaluation of the treatment of Adenomyosis with Dienogest, Etonogestrel Implant and Intrauterine System releasing Levonorgestrel – randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-722dg2y
Enrollment
Unknown
Registered
2025-02-06
Start date
2026-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Endometriosis of the uterus

Interventions

Treatment group with Dienogest 2mg orally, daily for 12 months with 40 women. Treatment group with Levorgestrel-releasing intrauterine system, which is an intrauterine device inserted that releases 20
C12.050.351.500.852.113

Sponsors

Universidade Estadual de Campinas - UNICAMP
Lead Sponsor
Universidade Estadual de Campinas - UNICAMP
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women; age between 18 and 45 years old; diagnosis of adenomyosis, both by magnetic resonance imaging and transvaginal ultrasound; have agreed to participate in the study and signed the Free and informed consent form

Exclusion criteria

Exclusion criteria: Women with uterine fibroids, endometrial polyps and other structural causes of abnormal uterine bleeding; women with cardiovascular, hepatic, renal failure or any other contraindications for the use of progestogens or the intrauterine system; women not having initiated sexual activity; women who cannot read or have some cognitive deficit that prevents them from understanding the questionnaires and the informed consent form

Design outcomes

Primary

MeasureTime frame
A similar rate of amenorrhea and reduction in pain symptoms is expected in the three groups

Secondary

MeasureTime frame
A similar reduction in fatigue is expected in all three groups and a greater reduction in uterine volume is expected in the Levonorgestrel-releasing intrauterine system and Etonogestrel implant groups

Countries

Brazil

Contacts

Public ContactDaniela Gomes

Universidade Estadual de Campinas - UNICAMP

yela@unicamp.br+55(19)35219306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)