NCT04047875View on ClinicalTrials.gov

Treatment of Prolonged Uterine Bleeding of Etonogestrel (ENG)-Releasing Implant

PHASE4CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

September 15, 2020

Primary Completion Date

May 5, 2023

Study Completion Date

May 5, 2023

Conditions
Breakthrough Bleeding
Interventions
DRUG

Norethisterone 10mg/day

NET-only pill (Norethisterone, Primolut-Nor®), 10 mg/day, 1 pill per day until 2 consecutive days without bleeding/spotting

DRUG

Placebo

Identically appearing placebo to Primolut-Nor®, 1 pill per day until 2 consecutive days without bleeding/spotting

Trial Locations (2)

14015-010

Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto

04023-061

UNIFESP, São Paulo

Sponsors

Collaborators (1)

Organon
All Listed Sponsors
collaborator

Organon

INDUSTRY

lead

University of Sao Paulo

OTHER