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LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women

We're studying contraceptives' effects on bone health in women.

Recruiting
14-45 years
Female
Phase 4

This study compares the effects of two contraceptive options on bone health in females aged 14 to 45. One option involves taking **LF111 or drospirenone (DRSP) 3.5 mg** chewable tablets. The other option uses **non-hormonal contraceptive methods**, which don't involve hormones. The primary goal is to study how these methods impact bone mineral density, especially in the lower spine, over a year (13 medication cycles). Participants will be split into two age groups: 14-17 (teens) and 18-45 (adults). The study also looks at changes in body fat and muscle, as well as general safety. Eligible participants must be post-menarcheal (having regular periods for at least two years) and premenopausal.

  • **Study Duration**: 12 months with 13 medication cycles.
  • **Visits**: Screening, treatment allocation, and on-site visits at 6 and 12 months.
  • **Eligibility**: Females aged 14-45, post-menarcheal, premenopausal, with no contraindications to study medications.
Study details
    Change in Bone Mineral Density
    Bone Loss

NCT05303636

Insud Pharma

10 October 2024

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