Multicentre, Open-Label Trial to Assess the Safety and Tolerability of LF111 (Drospirenone 4.0 mg) Over 6 Cycles in Female Adolescents, With a 7-Cycle Extension Phase

Phase 3

Withdrawn

• Conditions: contraception; fertility control

• Registration Number: NL-OMON40539
• Lead Sponsor: aboratorios León Farma S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Female adolescents aged 12-17 years and postmenarcheal for at least six months

Exclusion Criteria

Known contraindication or hypersensitivity to ingredients or excipients of IMP

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The objective of this trial is to evaluate safety and tolerability, including<br /><br>bleeding pattern<br /><br><br /><br>Safety endpoints: Treatment-emergent adverse events, Vital signs and Clinical<br /><br>laboratory parameters<br /><br>Tolerability endpoint: Vaginal bleeding pattern during treatment cycles 1-6<br /><br>(subject diaries)<br /><br>Other endpoint: IMP acceptability</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>