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

Join a study on contraceptives and bone health for women!

Recruiting
14-45 years
Female
Phase 4

Study Overview: This study checks how two types of birth control tablets, LF111 and drospirenone (also called DRSP), affect bone health in women. Bone Mineral Density (BMD) checks the strength of bones. The study compares these tablets to non-hormonal birth control methods over 12 months. It also looks at safety, body fat, and muscle changes.

Eligibility: Female participants should be aged 14 to 45, not pregnant, and have regular periods. Some health conditions, like certain bone or liver diseases, might exclude you from participating. The study is split into two age groups: 14-17 and 18-45.

  • Duration: The study lasts 12 months with visits at the start, 6 months, and 12 months.
  • Participation: You'll need to take tablets or use non-hormonal methods for 13 cycles.
  • Safety: Regular check-ups are done to ensure participant safety.

If you're interested, you must give written consent before starting. This study helps understand how these birth control methods affect bone health and overall safety. Participants are not randomized, so you can choose your preferred method.

Study details
    Change in Bone Mineral Density
    Bone Loss

NCT05303636

Insud Pharma

10 October 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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