Clinical trial NCT05303636: LF111 or Drospirenone Chew vs Non-hormonal Contraceptive Methods on Bone Mineral Density in Adolescent and Adult Women
Official title: A Multicenter, Open-label, Controlled Study to Investigate the Effect of Either LF111 or Drospirenone Chewable Tablets on Bone Mineral Density (BMD) in Adolescent and Adult Women in Comparison With Non-users of Hormonal Contraceptive Methods
Conditions: Change in Bone Mineral Density
Bone Loss
Summary: The primary objective of this study is to evaluate the impact of LF111 and drospirenone (DRSP) 3.5 mg chewable tablets on bone mineral density (BMD) at the lumbar spine after 12 months (13 medication cycles) of investigation in comparison to non-hormonal contraceptive methods. Secondary objectives include further evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on BMD and bone turnover after 12 months (13 medication cycles) in comparison to non-hormonal contraceptive methods and assessing the general safety and tolerability of LF111 and DRSP 3.5 mg chewable tablets in comparison to non-hormonal contraceptive methods. Exploratory objectives include evaluating the impact of LF111 and DRSP 3.5 mg chewable tablets on body fat and lean mass after 12 months (13 medication cycles) of investigation.
Interventions:
description: Drospirenone 4 mg tablet (LF1111) orally daily on days 1-24, followed by placebo tablet orally daily on days 25-28 (available in USA and Europe) or drospirenone 3.5 mg chewable tablet chewed daily on days 1-24, followed by placebo tablet chewed daily on days 25-28) (available in USA only).
name: drospirenone 4 mg oral tablet or drospirenone 3.5 mg chewable tablet
other_name: LF111 (drospirenone 4 mg tablet)
type: Drug
Study arms:
design_group_description: Subjects in the USA who choose to use the hormonal contraceptive method may choose between LF111 tablets or drospirenone (DRSP) 3.5 mg chewable tablets. 1/3 of subjects in the USA should receive DRSP 3.5 mg chewable tablets. The DRSP 3.5 mg chewable tablets are not available to subjects in Europe; subjects in Europe who choose to use the hormonal contraceptive method will only receive LF111.
design_group_title: Cohort 1 (adolescents aged 14-17) Hormonal Treatment Arm
design_group_type: Experimental
design_group_description: Subjects in this group will not receive any investigational product. They will be free to use a non-hormonal contraceptive method of their choice. Non-hormonal contraceptive methods include barrier contraceptive methods (condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), double barrier methods, non-hormonal IUD (e.g., copper IUD), surgical female sterilization, vasectomized partner, spermicides, and sexual abstinence.
design_group_title: Cohort 1 (adolescents aged 14-17) Non-Hormonal Contraceptive Arm
design_group_type: No Intervention
design_group_description: Subjects in the USA who choose to use the hormonal contraceptive method may choose between LF111 tablets or drospirenone (DRSP) 3.5 mg chewable tablets. 1/3 of subjects in the USA should receive DRSP 3.5 mg chewable tablets. The DRSP 3.5 mg chewable tablets are not available to subjects in Europe; subjects in Europe who choose to use the hormonal contraceptive method will only receive LF111.
design_group_title: Cohort 2 (adults aged 18-45) Hormonal Treatment Arm
design_group_type: Experimental
design_group_description: Subjects in this group will not receive any investigational product. They will be free to use a non-hormonal contraceptive method of their choice. Non-hormonal contraceptive methods include barrier contraceptive methods (condoms, female condoms, cervical caps, diaphragms, and contraceptive sponges), double barrier methods, non-hormonal IUD (e.g., copper IUD), surgical female sterilization, vasectomized partner, spermicides, and sexual abstinence.
design_group_title: Cohort 2 (adults aged 18-45) Non-Hormonal Contraceptive Method Arm
design_group_type: No Intervention
Sponsor: Insud Pharma SL
Collaborators: Chemo Research SL
Drug name mappings:
name: 屈螺酮
lang: CN
name: Drospirenone
lang: EN
name: ドロスピレノン
lang: JP