AzTrials
AzTrials

ContraceptionPhase 3NCT02269241

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

A Phase 3 study testing LF111 (drospirenone) in people with Contraception, run by Laboratories Leon Farma, S.A. at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To demonstrate the contraceptive efficacy of LF111 . To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111. Read more about this study

Who is it for?
Ages 15 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Contraception
What is being tested?
LF111 (drospirenone)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,552 participants
Where
37 sitesUnited States
Study dates
9 Oct 2014to 4 Oct 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.
Show all 45Show fewer
  • 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).
  • Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months).
  • Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent).
  • Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor V Leiden, Prothrombin mutation, Antiphospholipid antibodies) or bruising within the last 12 months prior to consent/assent.
  • Known or suspected HIV and/or hepatitis infection at screening.
  • Received a dose of depot medroxyprogesterone acetate (DMPA or Depo-Provera®) during the 10 months prior to consent/assent, or received any combined injectable contraceptive (e.g., Cyclofem®) during the six months prior to consent/assent, or no spontaneous menses since last injection.
  • Long-term treatment (longer than seven consecutive days within a month prior to V1b) of any medication that might interfere with the efficacy of hormonal contraceptives.
  • Prohibited medication include:
  • Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone)
  • Barbiturates
  • Rifampin
  • Bosentan
  • Griseofulvin
  • St. John's wort (hypericum perforatum)
  • Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to V1b).
  • Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent/assent.
  • Planned regular concomitant use of barrier contraceptive methods, spermicides, IUDs or other contraceptive measures (excepting occasional use for safety reasons, e.g., to reduce risk of infection).
  • Evidence or history of clinically significant psychiatric illness or suicide risk.
  • Participation in another trial of an investigational drug or device parallel to the current trial or less than 90 days before consent/assent, or previous participation in the current trial and dispensed trial medication.
  • Subject is a member of the investigator's or Sponsor's staff or a relative or family member thereof.
  • Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Southwest Clinical Research

    Albuquerque, New Mexico, 87109

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21224

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

  • Fellows Research Alliance, Inc.

    Bluffton, South Carolina, 29910

  • University of Cincinnati

    Cincinnati, Ohio, 45267

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

    Columbus, Ohio, 43213

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • WCCT Global

    Costa Mesa, California, 92626

  • Practice Research Organization

    Dallas, Texas, 75230

  • Downtown Women's Health Care

    Denver, Colorado, 80209

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • Physicians' Research Options

    Draper, Utah, 84020

  • TMC Life Research, Inc.

    Houston, Texas, 77054

  • Rosemark WomenCare Specialists

    Idaho Falls, Idaho, 83404

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Altus Research

    Lake Worth, Florida, 33461

  • Lawrence OBGYN Clinical Research, LLC

    Lawrenceville, New Jersey, 08648

  • Bluegrass Clinical Research, Inc

    Louisville, Kentucky, 40291

  • Miami Research Associates

    Miami, Florida, 33143

  • Eastern Carolina Women's Center

    New Bern, North Carolina, 28562

  • NYU School of Medicine

    New York, New York, 10016

  • Eastern Virginia Medical School

    Norfolk, Virginia, 23507

  • Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Clinical Research Of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • The Center for Women's Health & Wellness, LLC

    Plainsboro, New Jersey, 08536

  • Physicians' Research Options

    Pleasant Grove, Utah, 84062

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Women's Health Care Research Corp.

    San Diego, California, 92123

  • Fellows Research Alliance, Inc.

    Savannah, Georgia, 31406

  • Seattle Women's Health, Research, Gynecology

    Seattle, Washington, 98105

  • Meridien Research - St. Petersburg

    St. Petersburg, Florida, 33709

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06095

  • Meridien Research - Tampa

    Tampa, Florida, 33606

  • Comprehensive Clinical Trials, LLC

    West Palm Beach, Florida, 33409

  • Hawthorne Medical Research, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles

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

Read the detailed description

This trial is a prospective, multicenter, open-label, non-controlled trial in female subjects, including adolescents between the ages of 15+(inclusive) who present to the clinic seeking contraception, who are postmenarcheal and premenopausal.

At screening, informed consent will be obtained and the screening procedures will be performed. After confirmation of the subject's eligibility, the subject will be provided with the investigational product and trained in the use of an electronic diary. Afterwards, the subjects will attend visit the clinical site on Day 20±2 of the 1st, 3rd, 6th and 9th cycles and on Day 29+2 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th cycle visit.

The trial will include women who have never used hormonal contraceptives before consent (naïve users), women who have not used hormonal contraceptives in the past three months before consent or who have used hormonal contraceptives in the past but have a contraceptive-free time of less than three months before consent (previous users) as well as women directly switching from another hormonal method (switchers). Women who have used hormonal contraceptives in the past but have a contraceptive-free time of less than three months before consent are allowed to be included into the trial if they had at least one complete menstrual cycle before enrollment.

A population pharmacokinetic (PK) analysis planned in the whole subject population, will obtain sparse blood samples to determine plasma concentrations. In total, four blood samples will be collected: two samples each will be collected during the 1st cycle and during the 6th cycle of treatment.

Adverse events and safety information will be collected throughout the study.

Conditions
Contraception
Being tested
LF111 (drospirenone)
Keywords
contraception, hormonal oral contraceptive agents, hormonal oral contraceptive, oral contraceptive, drospirenone, LF111, birth control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LF111 (drospirenone)Drug

    Also called CF111

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

Study groups in NCT02269241
Study groupRoleWhat they receive
LF111 (drospirenone)Experimentalsingle treatment arm receives LF111
Receives: Drug: LF111 (drospirenone)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 13 months

Secondary outcomes (6)

  1. Number of Pregnancies (All)

    Pearl Index based on overall cycles (overall PI) in women aged ≤ 35 years (at the time of trial enrollment) (confirmed pregnancies)

    Measured: up to 13 months

  2. Number of Pregnancies (Method Failures)

    PI for method failures in women aged ≤ 35 years (at the time of trial enrollment) (confirmed pregnancies)

    Measured: up to 13 months

  3. Pregnancy Ratio

    Pregnancy ratio in women aged ≤ 35 years (at the time of trial enrollment)

    Measured: up to 13 months

  4. Overall PI, PI for Method Failures

    Overall PI, PI for method failures, PI (using evaluable cycles) and pregnancy ratio (life table analysis) in all women and in women up to 13 months (confirmed pregnancies)

    Measured: up to 13 months

  5. Number of Participants With Adverse Events as a Measure of Safety

    Adverse events and changes in vital signs, clinical laboratory parameters

    Measured: up to to 13 months

  6. Tolerability; Vaginal Bleeding Pattern

    Vaginal bleeding pattern

    Measured: up to 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2014 (estimated)
  2. Study start9 Oct 2014
  3. Primary completion4 Oct 2017
  4. Study completion4 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02269241
Sponsor's protocol ID
CF111/303
Status last verified
Oct 2017
First submitted
6 Oct 2014
Last updated
6 Aug 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 33008401

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LF111 (drospirenone) in people with Contraception, run by Laboratories Leon Farma, S.A. at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Pregnancies (Evaluable Cycles) (time frame: up to 13 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02269241, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in