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

NCT05461573 | Completed Phase 3 FDA Drug

• 1 other identifier: CF113-303
• Study Type: interventional
• Target: 1,542
• Locations: 2 countries
• Sites: 47

Brief 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.

Conditions

Contraception; Change in Bone Mineral Density

Keywords

Contraceptive Method Switching

Outcome Measures

Primary Outcomes (1)

• Part A (Efficacy Assessment): Number of pregnancies in subjects ≤35 years of age (at the time of screening).

  Calculated by Pearl Index.

  12 months

Secondary Outcomes (7)

• Part A (Efficacy Assessment): Number of pregnancies from exposure cycles in subjects ≤35 years of age.

  12 months

• Part A (Efficacy Assessment): Number of pregnancies from method failures in subjects ≤35 years of age.

  12 months

• Part A (Efficacy Assessment): Pregnancy ratio from evaluable cycles, exposure cycles, and perfect cycles in subjects ≤35 years of age.

  12 months

• Part A (Efficacy Assessment): Number of pregnancies from exposure cycles, method failures, and evaluable cycles in all subjects.

  12 months

• Part A (Efficacy Assessment): Pregnancy ratio in all subjects.

  12 months

Other Outcomes (16)

• Part A (Primary Safety Assessment): Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), drug-related AEs, and treatment-emergent AEs.

  12 months

• Part A (Primary Safety Assessment): Incidence and severity of abnormal clinical findings on physical examination, gynecological examination, and transvaginal ultrasound examination.

  12 months

• Part A (Primary Safety Assessment): Incidence and severity of mastodynia/mastalgia and dysmenorrhea.

  12 months

Study Arms (2)

Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113

EXPERIMENTAL

All subjects enrolled in the study will participate in Part A of the study. Part A of the study will investigate the efficacy, safety, and tolerability of LPRI-CF113.

Drug: Drospirenone

Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45

EXPERIMENTAL

A subgroup of subjects from Part A that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.

Drug: Drospirenone

Interventions

Drospirenone DRUG

LPRI-CF113 consists of 24 active white tablets containing drospirenone (DRSP) 4 mg followed by 4 active pink tablets containing DRSP 2.8 mg, taken orally once daily for 28 consecutive days, in consecutive cycles for 12 months (13 medication cycles) without a break in daily tablet intake.

Also known as: LPRI-CF113

Part A - An investigation of the efficacy, safety, and tolerability of LPRI-CF113; Part B - The effect of LPRI-CF113 on bone mineral density in a subgroup age 18-45

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects must be willing and able to provide written informed consent (for adults) or assent (for adolescents \<18 years of age) and comply with all study procedures, prohibitions, restrictions, and scheduled visits
• Subjects must be female, healthy, sexually active, postmenarcheal, premenopausal, and of childbearing potential, between 13 and 45 years of age (inclusive at the time of screening) and at risk for pregnancy
• Note: Childbearing potential is defined as subjects who are ovulating, premenopausal, and not surgically sterile (ie, have not undergone hysterectomy, salpingectomy, or bilateral oophorectomy). Subjects that have undergone unilateral oophorectomy will not be considered surgically sterile and may be included in the study
• Subjects must be willing to have vaginal intercourse (with a genetically male partner) throughout the Treatment Period (ie, during each medication cycle) without using a secondary (eg, spermicides) or emergency method of contraception
• Subjects must have a BMI of 18 kg/m2 or higher
• Subjects must have a systolic blood pressure of 159 mmHg or lower and a diastolic blood pressure of 99 mmHg or lower
• Note: The median of 3 blood pressure measurements will be used for this criterion
• Note: Subjects are required to rest for 5 minutes prior to the first blood pressure measurement and for 1 minute between subsequent measurements. Measurements done without appropriate preparation of the subject (excluding caffeine use, smoking, or excessive physical activity) should not be considered, and the measurement should be repeated upon appropriate preparation of the subject
• Subjects must be regularly menstruating (with cycle length between 21 and 35 days) for at least 3 months prior to the signing of the Informed Consent Form
• Note: Breastfeeding women can be included 6 weeks after delivery irrespective of menstrual cycles post-delivery
• Subjects must agree to not use any secondary (eg, spermicides) or emergency contraceptive methods during the study period
• Subjects must not be enrolled or plan to enroll in any other clinical study during the study period
• Subjects must be willing to use the study drug (LPRI-CF113) for 13 (28-day) medication cycles, and be willing to use the provided diary
• Subjects must generally be in good physical and mental health based on a medical history and a physical examination performed by the Investigator at screening

You may not qualify if:

• PART A:
• The subject is pregnant at the time of screening
• The subject has a desire to become pregnant at the time of screening
• Note: The subject will be asked if she has a desire for pregnancy at screening (and at each study visit). If a positive answer is given at screening, the subject will be excluded
• The subject plans regular concomitant use of barrier contraceptive methods, spermicides, intrauterine device, other contraceptive measures, prohibited medications, and drugs contraindicated for study drug
• The subject has an abnormal and clinically significant finding on pelvic, breast, or ultrasound examination at screening based on the judgment of the Investigator
• The subject has an abnormal and clinically significant finding on physical examination, clinical laboratory assessments (chemistry, hematology, urinalysis), or 12-lead ECG assessment based on the judgment of the Investigator
• The subject has received any of the following:
• A progestin-releasing intra-uterine device or contraceptive implant within 2 months prior to screening or
• A beta-human chorionic gonadotropin (β-hCG) or co-medication containing β-hCG within 1 month prior to screening
• The subject at the time of screening has a history of primary amenorrhea or secondary amenorrhea (with or without known etiology)
• Note: Primary amenorrhea is defined as no menarche by 16 years of age with normal secondary sexual characteristics
• Note: Secondary amenorrhea is defined as the absence of menses for 3 months in the setting of previously normal (ie, regular) menstruation
• The subject has a current male sexual partner with a history of infertility, vasectomy, or bilateral orchiectomy
• The subject has an abnormal Pap smear finding of low-grade squamous intraepithelial lesion or higher at screening or 6 months prior to screening. Subjects \<21 years of age at screening do not require a Pap smear

Sponsors & Collaborators

• Insud Pharma: lead
• Chemo Research: collaborator

Study Sites (47)

Alabama Clinical Therapeutics, LLC

Alabaster, Alabama, 35007, United States

Location

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Del Sol Research Management

Tucson, Arizona, 85715, United States

Location

Eclipse Clinical Research

Tucson, Arizona, 85745, United States

Location

Cornerstone Research Institute - Longwood

Altamonte Springs, Florida, 32701, United States

Location

Encore Medical Research of Boynton Beach LLC.

Boynton Beach, Florida, 33436, United States

Location

Women's Medical Research Group

Clearwater, Florida, 33759, United States

Location

Direct Helpers Research Center

Hialeah, Florida, 33012, United States

Location

Inpatient Research Clinic, LLC

Hialeah, Florida, 33013, United States

Location

Vital Pharma Research, Inc.

Hialeah, Florida, 33016, United States

Location

Encore Medical Research, LLC

Hollywood, Florida, 33021, United States

Location

Global Research Associates

Homestead, Florida, 33030, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Florida International Medical Research

Miami, Florida, 33155, United States

Location

New Age Medical Research Corporation

Miami, Florida, 33186, United States

Location

SJ Research Institute

Miami, Florida, 33186, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

American Research Centers of Florida

Pembroke Pines, Florida, 33027, United States

Location

Comprehensive Clinical Trials

West Palm Beach, Florida, 33409, United States

Location

Encore Medical Research of Weston LLC

Weston, Florida, 33331, United States

Location

Fellows Research Alliance

Savannah, Georgia, 31406, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates

Metairie, Louisiana, 70001, United States

Location

Eastern Clinical Research Associates

New Orleans, Louisiana, 70127, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Unified Women's Clinical Research - Raleigh

Raleigh, North Carolina, 27607, United States

Location

Unified Women's Clinical Research - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Clinohio Research Services

Columbus, Ohio, 43213, United States

Location

AC Clinical Research

Tiffin, Ohio, 44883, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

The Research Center of the Upstate

Greenville, South Carolina, 29607, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Discovery Clinical Trials

Dallas, Texas, 75225, United States

Location

TMC Life Research

Houston, Texas, 77054, United States

Location

FMC Science

Lampasas, Texas, 76550, United States

Location

Maximos OB/GYN

League City, Texas, 77573, United States

Location

Austin Regional Clinic ARC Clinical Research at Kelly Lan

Pflugerville, Texas, 78660, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Mt. Olympus Medical Research- Sugar Land Texas

Sugar Land, Texas, 77479, United States

Location

Eastern Virginia Medical School (EVMS)

Norfolk, Virginia, 23507, United States

Location

Virginia Women's Health Associates

Reston, Virginia, 20190, United States

Location

Clinique RS

Québec, G1V 3M7, Canada

Location

Related Publications (10)

• 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.

  PMID: 10836659 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.

  PMID: 22436400 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.

  PMID: 10752720 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.

  PMID: 21664507 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.

  PMID: 23421366 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.

  PMID: 3539509 BACKGROUND

MeSH Terms

Conditions

Contraception Behavior

Interventions

drospirenone

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Officials

• Enrico Colli, MD

  Chemo Research SL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects enrolled in the study will participate in Part A of the study and receive the experimental drug LPRI-CF113 (drospirenone). Part A will investigate the efficacy, safety, and tolerability of LPRI-CF113. A subgroup of subjects that are age 18-45 and without further exclusion criteria to Part B will be enrolled in Part B of the study. Part B of the study will investigate the effects of LPRI-CF113 on bone mineral density.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: August 2, 2022
• Primary Completion: August 5, 2024
• Study Completion: May 27, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

CA (1); US (46)