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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

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 - CF111/304

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40539
Enrollment
20
Registered
2014-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

contraception contraception fertility control

Interventions

The study will start with a screening visit. During the screening visit standard medical assessments including safety laboratory tests (blood draw, urine collection, pregnancy test), a physical exam

Sponsors

Laboratorios León Farma S.A
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Known contraindication or hypersensitivity to ingredients or excipients of IMP

Design outcomes

Primary

MeasureTime frame
The objective of this trial is to evaluate safety and tolerability, including bleeding pattern Safety endpoints: Treatment-emergent adverse events, Vital signs and Clinical laboratory parameters Tolerability endpoint: Vaginal bleeding pattern during treatment cycles 1-6 (subject diaries) Other endpoint: IMP acceptability—

Secondary

MeasureTime frame
n.a.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)