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

Completed · Phase 3 · Has a placebo group

Conditions studied: Contraception

In brief

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

Key facts

Study ID

NCT02269241

Run by

Laboratories Leon Farma, S.A.

People needed

1552

Starts

2014-10-09

Expected to finish

2017-10-04

Last updated by the study team

2019-08-06

Who can join

Age: 15 and older. Sex: female. Healthy volunteers: accepted.

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.
• Agree not to participate in any other clinical trials during the course of this trial.

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
• Valvular heart disease with thrombogenic complications
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast
• Known or suspected sex-steroid sensitive malignancies
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Liver tumor (benign or malignant) or active clinically significant liver disease.
• Uncontrolled thyroid disorder (i.e., on stable dose of thyroid replacement for less than two months).

Where it is running

• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• WCCT Global — Costa Mesa, California, United States
• Women's Health Care Research Corp. — San Diego, California, United States
• Downtown Women's Health Care — Denver, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Altus Research — Lake Worth, Florida, United States
• Miami Research Associates — Miami, Florida, United States
• Segal Institute for Clinical Research — North Miami, Florida, United States
• Meridien Research - St. Petersburg — St. Petersburg, Florida, United States
• Meridien Research - Tampa — Tampa, Florida, United States
• Comprehensive Clinical Trials, LLC — West Palm Beach, Florida, United States
• Fellows Research Alliance, Inc. — Savannah, Georgia, United States
• Rosemark WomenCare Specialists — Idaho Falls, Idaho, United States
• Bluegrass Clinical Research, Inc — Louisville, Kentucky, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Lawrence OBGYN Clinical Research, LLC — Lawrenceville, New Jersey, United States
• The Center for Women's Health & Wellness, LLC — Plainsboro, New Jersey, United States
• Southwest Clinical Research — Albuquerque, New Mexico, United States
• NYU School of Medicine — New York, New York, United States
• Eastern Carolina Women's Center — New Bern, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Hawthorne Medical Research, Inc. — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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