NCT04792385

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

A Multicenter, Open-label, Single-Arm Study to Evaluate the Safety, Compliance and Pharmacokinetics Associated With the Use of a Combined Oral Contraceptive Containing 15 mg Estetrol Monohydrate and 3 mg Drospirenone in Post-menarchal Female Adolescents for 6 Cycles

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, compliance, and pharmacokinetics profile of estetrol monohydrate (E4) 15 mg combined with drospirenone (DRSP) 3 mg in post-menarchal participants between the age of 12 and 17 years + 2 months.

Detailed description

This is a Phase 3, open-label, non-controlled study in healthy post-menarchal female participants who will be enrolled to receive once daily E4/DRSP 15/3 mg for six (6) 28-day cycles in a 24/4-day regimen (i.e. 24 days of active tablets followed by 4 days of placebo tablets \[4-day hormone-free interval\]). The study will include 6 visits: At screening visit (Visit 1), informed consent will be signed by the participants and their parent(s) or legal representative(s) and the screening procedures will be performed. The site will also complete an Eligibility confirmation phone call to the participant after Visit 1. During the enrollment visit (Visit 2, between Days 12 and 19 of the pre-treatment cycle), eligibility criteria will be reviewed and the participant participation will be confirmed. Participants will be trained in the use of an electronic diary and will receive the study drug. A follow-up call will be performed after Visit 2, within 7 days following the first investigational product intake. Afterwards, the participants will attend 3 on-treatment visits at the clinical site \[between Days 14 and 21 of the Cycle 1(Visit 3), Cycle 3 (Visit 4), and Cycle 6 (Visit 5)\] and one visit after end of Cycle 6 (Visit 6). For participants who consent to participate in a pharmacokinetics sub-study, blood samples for this sub-study will be taken at Visit 3 and Visit 5. Adverse events will be followed throughout the study.

Conditions

• Safety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-12-28
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2021-03-11
• Last updated: 2023-12-22

Locations

23 sites across 6 countries: Estonia, Finland, Georgia, Latvia, Poland, Sweden