NCT04792385 - Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents | Biotech Hunter

Enrollment

145

Participants

Timeline

Start Date

December 28, 2020

Primary Completion Date

November 24, 2023

Study Completion Date

November 24, 2023

Conditions

Safety

Interventions

DRUG

E4/DRSP 15/3 mg combined tablet

One E4/DRSP 15/3 mg combined tablet once per day for 24 days followed by 4 days of placebo tablets; this 28-day cyclic regimen should be taken for 6 consecutive cycles.

Trial Locations (23)

6004

Estetra Study Site, Batumi

Unknown

KVL Medical Office/KVL Arstikabinet, Pärnu

East-Tallinn Central Hospital, Tallinn

Sexual Health Clinic, Tallinn, Tallinn

Sexual Health Clinic, Tartu, Tartu

VL-Medi Oy, Helsinki

Lääkärikeskus Mehiläinen, Kuopio

Lääkärikeskus Gyneko, Oulu

A. Krumpane practice, Daugavpils

Childrens Clinical University Hospital, Riga

Akardo Medsite at Sturebadet Health Care, Stockholm

Karolinska University, Department of Gynecology and Reproductive Medicine, Stockholm

Karolinska University, WHO Center, Stockholm

0112

Estetra Study Site, Tbilisi

0159

Estetra Study Site, Tbilisi

0160

Estetra Study Site, Tbilisi

15-224

Estetra Study Site, Bialystok

40-301

Estetra Study Site, Katowice

20-093

Estetra Study Site, Lublin

27-400

Estetra Study Site, Ostrowiec Świętokrzyski

60-535

Estetra Study Site, Poznan

05-090

Estetra Study Site, Raszyn

50-414

Estetra Study Site, Wroclaw