Effects of the oral monophasic contraceptive pill CG 5025 (Belara/0,03 mg etinyl estradiol and 2 mg chlormadinonacetate) on the cosmetic hairquality in women wishing to use hormonal contraception

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007489-39-DE

Enrollment

Registered

2008-01-30

Start date

2008-03-25

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

unaesthetic hairquality in woman wishing to use hormonal contraception

Interventions

Trade Name: Belara (CG 5025) Product Name: Belara Product Code: CG 5025 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ethinyl estradiol Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • age >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • pregnancy, lactation; • alkoholism, drug addiction; • participation on other clinical trials at the same time or within the last 30 days; • taking hormonal contraception within the last 4 weeks or especially antiandrogenetic contraception within the last 3 month • no written informed consent; • no gynaecological confirmation that participation is medically unobjectionable

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of the trial is the change of hairquality, evaluated with a clinical score (criteria of the total score: capillitium seborrhoe, hairvolume, condition of hair and capillitium). ;Secondary Objective: Secondary objectives of the trial are the evaluation of seborrhoe (capillitium and forehead) and stratum corneum hydration (retroauricularis and forehead), microscopic evaluation of the haircondition with REM-photos, digital measurement of hairgrowth and hairloss with Trichoscan, the evaluation of hairvolume with photos of the hairpart and androgenization symptoms such as acne and hirsutism. Furthermore will be a patients self-evaluation score (changes in hairquality, attractiveness and quality of life) used. ;Primary end point(s): Improvement of the clinical score of hairquality	—

Measure

Time frame

Main Objective: Main objective of the trial is the change of hairquality, evaluated with a clinical score (criteria of the total score: capillitium seborrhoe, hairvolume, condition of hair and capillitium). ;Secondary Objective: Secondary objectives of the trial are the evaluation of seborrhoe (capillitium and forehead) and stratum corneum hydration (retroauricularis and forehead), microscopic evaluation of the haircondition with REM-photos, digital measurement of hairgrowth and hairloss with Trichoscan, the evaluation of hairvolume with photos of the hairpart and androgenization symptoms such as acne and hirsutism. Furthermore will be a patients self-evaluation score (changes in hairquality, attractiveness and quality of life) used. ;Primary end point(s): Improvement of the clinical score of hairquality

—

Countries

Germany

Outcome results

None listed

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