Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females

Summary

This study will be in two parts, Part A and Part B. The primary objective of Part A is to evaluate the contraceptive efficacy of LPRI-CF113. The secondary objective of Part A is to evaluate the safety and tolerability of LPRI-CF113. The primary objective of Part B is to evaluate the impact of LPRI-CF113 on bone mineral density (BMD) at the lumbar spine (L1-L4) after 12 months (13 medication cycles). The secondary objective of Part B is to evaluate the impact of LPRI-CF113 on BMD and bone turnover after 12 months (13 medication cycles) at the femoral neck, total hip, and total body.

Timeline

Start

2022-08-02

Primary completion

2024-08-05

Completion

2025-05-27

Publications

• Background Rosenbaum P, Schmidt W, Helmerhorst FM, Wuttke W, Rossmanith W, Freundl F, Thomas K, Grillo M, Wolf A, Heithecker R. Inhibition of ovulation by a novel progestogen (drospirenone) alone or in combination with ethinylestradiol. Eur J Contracept Reprod Health Care. 2000 Mar;5(1):16-24. doi: 10.1080/13625180008500376.
• Background SLYND (drospirenone) [prescribing information]. Florham Park, NJ. Exeltis USA, Inc. May 2019.
• Background Investigator's Brochure for Drospirenone Only Pill - LF111. Edition No. 12.0, 18 March 2021.
• Background Cibula D, Skrenkova J, Hill M, Stepan JJ. Low-dose estrogen combined oral contraceptives may negatively influence physiological bone mineral density acquisition during adolescence. Eur J Endocrinol. 2012 Jun;166(6):1003-11. doi: 10.1530/EJE-11-1047. Epub 2012 Mar 21.
• Background Beksinska ME, Smit JA. Hormonal contraception and bone mineral density. Expert Rev of Obstet Gynecol. 2011;6(3):305-319.
• Background Investigator's Brochure for Drospirenone 4 mg and 2.8 mg Oral Tablets - LPRI-CF113. Edition No. 2.2, 10 August 2022.
• Background Thomas SL, Ellertson C. Nuisance or natural and healthy: should monthly menstruation be optional for women? Lancet. 2000 Mar 11;355(9207):922-4. doi: 10.1016/S0140-6736(99)11159-0. No abstract available.
• Background Burkman R, Bell C, Serfaty D. The evolution of combined oral contraception: improving the risk-to-benefit ratio. Contraception. 2011 Jul;84(1):19-34. doi: 10.1016/j.contraception.2010.11.004. Epub 2010 Dec 24.
• Background Bitzer J. Hormone withdrawal-associated symptoms: overlooked and under-explored. Gynecol Endocrinol. 2013 Jun;29(6):530-5. doi: 10.3109/09513590.2012.760194. Epub 2013 Feb 20.
• Background Belsey EM, Machin D, d'Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60. doi: 10.1016/0010-7824(86)90006-5.

Drugs

Indications

No indication recorded.