Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles

NCT02269241 | Completed Phase 3 Results

• 1 other identifier: CF111/303
• Study Type: interventional
• Target: 1,552
• Locations: 1 country
• Sites: 37

Brief Summary

To demonstrate the contraceptive efficacy of LF111 . To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111.

Conditions

Contraception

Keywords

contraception; hormonal oral contraceptive agents; hormonal oral contraceptive; oral contraceptive; drospirenone; LF111; birth control

Outcome Measures

Primary Outcomes (1)

• Number of Pregnancies (Evaluable Cycles)

  Pearl index (PI) from Evaluable Cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment). The PI calculation was based on the following formula: PI(evaluable cycles)= (∑ on-drug confirmed pregnancy ∈{exposure cycles})/(#{exposure cycles} ) X 1300

  up to 13 months

Secondary Outcomes (6)

• Number of Pregnancies (All)

  up to 13 months

• Number of Pregnancies (Method Failures)

  up to 13 months

• Pregnancy Ratio

  up to 13 months

• Overall PI, PI for Method Failures

  up to 13 months

• Number of Participants With Adverse Events as a Measure of Safety

  up to to 13 months

Other Outcomes (2)

• Number of Pregnancies (by BMI and Weight)

  up to 13 months

• Overall Pregnancies

  up to 13 months

Study Arms (1)

LF111 (drospirenone)

EXPERIMENTAL

single treatment arm receives LF111

Drug: LF111 (drospirenone)

Interventions

LF111 (drospirenone) DRUG

One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.

Also known as: CF111

LF111 (drospirenone)

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women with no upper age limit.
• Female subjects at risk of pregnancy, between the ages of 15 and 17 (inclusive) provided that
• Applicable national, state and local laws allow subjects in this age group to consent/assent to receive contraceptive services, and
• All applicable laws and regulations regarding the informed consent/assent of the subjects to participate in clinical trials are observed.
• Regular cycles during the last six months before consent/assent when not using hormonal contraception.
• At least three complete menstrual cycles after delivery (only applicable for women who were pregnant within the last six months and for non-breastfeeding women). Breastfeeding women can be included six weeks after delivery irrespective of menstrual cycles post-delivery.
• At screening, maximum systolic blood pressure (median value of three values) ≤ 159 mm Hg and diastolic blood pressure (median value of three values) ≤ 99 mm Hg.
• Be able and willing to provide written informed consent or assent if the subject is adolescent, prior to undergoing any trial-related procedure.
• Willing to use trial contraception for thirteen 28-day cycles.
• Be willing to have intercourse each cycle of trial without the need to use back-up contraceptive.
• Be willing to state that, to her best knowledge, her male sexual partner(s):
• Has not had a vasectomy or been previously diagnosed as infertile.
• Has not been previously diagnosed or suspected of human immunodeficiency virus (HIV) unless he has subsequently had a negative HIV test.
• Has not been known to have engaged in homosexual intercourse in the past five years unless he has had negative HIV test results since then.
• Has not shared injection drug needles in the past unless he has had a negative HIV test at least six weeks since last use.

You may not qualify if:

• Pregnant.
• Subject is known to or suspected of not being able to comply with the trial protocol, the use of the trial medication or the use of the trial diary.
• History of infertility.
• Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
• Unexplained amenorrhea.
• Known polycystic ovary syndrome.
• Women ≥21 years of age with a Papanicolaou (pap) smear reading LGSIL or higher at screening (or six months prior to screening date). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASC-US) can be used as an adjunctive test.
• Subjects with ASC-US can be included if they are negative for high-risk HPV strains.
• Subjects \<21 years of age do not require a pap smear.
• Known contraindication or hypersensitivity to ingredients or excipients of the IMP (Investigational Medicinal Product), including:
• Renal insufficiency
• Hepatic dysfunction
• Adrenal insufficiency
• Current or history of venous thrombophlebitis or thromboembolic disorders (venous thromboembolism, which includes deep vein thrombosis and pulmonary embolism)
• Current or history of cerebral-vascular or coronary-artery disease

Sponsors & Collaborators

• Laboratories Leon Farma, S.A.: lead
• Chemo France: collaborator

Study Sites (37)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

Location

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

WCCT Global

Costa Mesa, California, 92626, United States

Location

Women's Health Care Research Corp.

San Diego, California, 92123, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80209, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06095, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, 33161, United States

Location

Meridien Research - St. Petersburg

St. Petersburg, Florida, 33709, United States

Location

Meridien Research - Tampa

Tampa, Florida, 33606, United States

Location

Comprehensive Clinical Trials, LLC

West Palm Beach, Florida, 33409, United States

Location

Fellows Research Alliance, Inc.

Savannah, Georgia, 31406, United States

Location

Rosemark WomenCare Specialists

Idaho Falls, Idaho, 83404, United States

Location

Bluegrass Clinical Research, Inc

Louisville, Kentucky, 40291, United States

Location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21224, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Lawrence OBGYN Clinical Research, LLC

Lawrenceville, New Jersey, 08648, United States

Location

The Center for Women's Health & Wellness, LLC

Plainsboro, New Jersey, 08536, United States

Location

Southwest Clinical Research

Albuquerque, New Mexico, 87109, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Eastern Carolina Women's Center

New Bern, North Carolina, 28562, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Columbus Obstetricians-Gynecology, Inc./Radiant Research, Inc.

Columbus, Ohio, 43213, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research Of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Fellows Research Alliance, Inc.

Bluffton, South Carolina, 29910, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Practice Research Organization

Dallas, Texas, 75230, United States

Location

TMC Life Research, Inc.

Houston, Texas, 77054, United States

Location

Physicians' Research Options

Draper, Utah, 84020, United States

Location

Physicians' Research Options

Pleasant Grove, Utah, 84062, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Seattle Women's Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Palacios S, Colli E, Regidor PA. Efficacy and cardiovascular safety of the new estrogen-free contraceptive pill containing 4 mg drospirenone alone in a 24/4 regime. BMC Womens Health. 2020 Oct 2;20(1):218. doi: 10.1186/s12905-020-01080-9.

  PMID: 33008401 DERIVED

MeSH Terms

Interventions

drospirenone

Results Point of Contact

• Title: Dr. Enrico Colli, Chief Scientific Officer
• Organization: Exeltis

enrico.colli@exeltis.com

+34917711500

Study Officials

• Enrico Colli, MD

  Exeltis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: October 21, 2014
• Study Start: October 9, 2014
• Primary Completion: October 4, 2017
• Study Completion: October 4, 2017
• Last Updated: August 6, 2019
• Results First Posted: July 23, 2019

Record last verified: 2017-10

Locations

US (37)