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Treating Endometriosis: Pill of Dienogest alone vs. Pill of Dienogest with Hormonal Intrauterine Device - a randomized clinical trial

Endometriosis treatment with Dienogest Monotherapy or Dienogest associated to Intrauterine Dispositive of Levonorgestrel - a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-68j3f26
Enrollment
Unknown
Registered
2024-07-16
Start date
2024-09-01
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

Interventions

This is a randomized controlled clinical trial with two groups. A total of 80 women who meet the eligibility criteria will be allocated. Women followed in the endometriosis outpatient clinic will be i
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Sponsors

Universidade Estadual de Campinas
Lead Sponsor
Hospital da Mulher José Aristodemo Pinotti - CAISM
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 45 years. Diagnosis of endometriosis by specific imaging examination ultrasound, magnetic resonance imaging (MRI). Present at study entry with complaints of pelvic pain and/or deep dyspareunia. Agree to the use of dienogest or levonorgestrel intrauterine device (LNG IUD). No contraindications to the use of levonorgestrel intrauterine device (LNG IUD). No desire for pregnancy during the one-year study period

Exclusion criteria

Exclusion criteria: Asymptomatic women. Women who have not initiated sexual activity. Women with psychiatric or neurological disorders that compromise the ability to respond to the questionnaires developed such as schizophrenia, neurodegenerative disorders, severe depression. Women undergoing treatment for chronic systemic diseases that lead to painful symptoms fibromyalgia, interstitial cystitis, neuropathic pain. History of abdominal surgery hysterectomy, colectomy, exploratory laparotomy, complicated appendectomy

Design outcomes

Primary

MeasureTime frame
We hope to find a better control of pain in endometriosis in use of levonorgestrel intrauterine device associated to dienogest

Secondary

MeasureTime frame
We hope to find reduction in endometriosis lesions' volume, such as endometriomas

Countries

Brazil

Contacts

Public ContactRenan Nakamura

Universidade Estadual de Campinas

renanm@unicamp.br+55(19)35219306

Outcome results

None listed

Source: REBEC (via WHO ICTRP)