Oral contraception
Conditions
Brief summary
Cohort 1: Adolescents Mean absolute change in lumbar spine (L1-L4) Z-score from baseline to 12 months as measured by dual-energy X-ray absorptiometry (DXA) Cohort 2: Adults Mean percentage change in lumbar spine (L1-L4) BMD from baseline to 12 months as measured by DXA
Detailed description
Please refer to the Protocol for Cohort 1 & 2 (Section 7), Changes in body weight and body mass index (BMI), Mean absolute and relative changes in routine laboratory values from baseline to 6 months and to 12 months, Mean absolute and relative changes in serum estradiol (E2) levels in the hormonal treatment arm from baseline to 6 months and to 12 months, Adverse events
Interventions
DRUGPlacebo (green tablets: inactive ingredients: lactose
DRUGmaize starch
DRUGpovidone
DRUGsilica
DRUGcolloidal anhydrous magnesium stearate hypromellose triacetin polysorbate 80 titanium dioxide indigo carmine aluminium lake yellow iron oxide).
DRUGDROSPIRENONE
Sponsors
Chemo Research S.L.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Adolescents Mean absolute change in lumbar spine (L1-L4) Z-score from baseline to 12 months as measured by dual-energy X-ray absorptiometry (DXA) Cohort 2: Adults Mean percentage change in lumbar spine (L1-L4) BMD from baseline to 12 months as measured by DXA | — |
Secondary
| Measure | Time frame |
|---|---|
| Please refer to the Protocol for Cohort 1 & 2 (Section 7), Changes in body weight and body mass index (BMI), Mean absolute and relative changes in routine laboratory values from baseline to 6 months and to 12 months, Mean absolute and relative changes in serum estradiol (E2) levels in the hormonal treatment arm from baseline to 6 months and to 12 months, Adverse events | — |
Countries
Czechia, Poland
Outcome results
None listed