Multi-center, open-label, randomized, parallel-group comparison of cycle control, bleeding pattern, lipid and carbohydrate metabolism of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) in a 21-day regimen vs. a comparator patch EVRA® (0.6 mg ethinylestradiol and 6 mg norelgestromin) in a 21-day regimen for 7 cycles in 400 women - Transdermal contraceptive patch: EU cycle control study (vs. EVRA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-007308-27-NL

Enrollment

400

Registered

2009-02-04

Start date

2009-06-23

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Prevention of pregnancy MedDRA version: 9.1 Level: LLT Classification code 10060346 Term: Transdermal contraception

Interventions

Product Name: FC Patch Low Product Code: material no. 80876395 Pharmaceutical Form: Transdermal patch INN or Proposed INN: Ethinylestradiol CAS Number: 57-63-6 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Signed and dated informed consent 2.Healthy woman requesting contraception 3.Age: 18 – 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent 4.Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) 5.History of regular cyclic menstrual periods Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy or lactation, obesity (BMI > 30), hypersensitivity to any ingredient of the study drug, significant skin reaction to transdermal preparations, any diseases/conditions that can compromise the functions of the body system (resulting in altered absorption/ accumulation/ metabolism/ excretion of the study drug), any diseases/ conditions that may worsen under hormonal treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the bleeding pattern and cycle control parameters of the transdermal contraceptive patch FC Patch Low (material no. 80876395 containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg EE and 6 mg NGMN).;Secondary Objective: The secondary objectives are the contraceptive efficacy, safety profile (including lipid/carbohydrate metabolism), and population pharmacokinetics of FC Patch Low in comparison to the EVRA patch. Additionally, compliance and subjective assessment of the treatment will be evaluated as secondary objectives.;Primary end point(s): Cycle control parameters and bleeding pattern indices	—

Measure

Time frame

Main Objective: The primary objective is to investigate the bleeding pattern and cycle control parameters of the transdermal contraceptive patch FC Patch Low (material no. 80876395 containing 0.55 mg EE and 2.1 mg GSD) in comparison to the EVRA patch (containing 0.6 mg EE and 6 mg NGMN).;Secondary Objective: The secondary objectives are the contraceptive efficacy, safety profile (including lipid/carbohydrate metabolism), and population pharmacokinetics of FC Patch Low in comparison to the EVRA patch. Additionally, compliance and subjective assessment of the treatment will be evaluated as secondary objectives.;Primary end point(s): Cycle control parameters and bleeding pattern indices

—

Countries

Austria, Czech Republic, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026