We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02269241
First Posted: October 21, 2014
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Chemo France
Information provided by (Responsible Party):
Chemo ( Laboratories Leon Farma, S.A. )
  Purpose
To demonstrate the contraceptive efficacy of LF111. To demonstrate the safety and tolerability of LF111 and assessment of pharmacokinetics of LF111.

Condition Intervention Phase
Contraception Drug: LF111 (drospirenone) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chemo ( Laboratories Leon Farma, S.A. ):

Primary Outcome Measures:
  • Number of pregnancies (after correction) [ Time Frame: up to 13 months ]
    Number of pregnancies occurring after correction for back-up contraception and sexual activity


Secondary Outcome Measures:
  • Number of pregnancies (all) [ Time Frame: up to 13 months ]
    All pregnancies which occur during the trial

  • Number of pregnancies (method failures) [ Time Frame: up to 13 months ]
    Number of pregnancies that occurred due to women who used the product incorrectly


Other Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to to 13 months ]
    Adverse events and changes in vital signs, clinical laboratory parameters, vaginal bleeding patterns

  • Drospirenone plasma concentration [ Time Frame: at 6 months ]
  • Drospirenone area under the curve [ Time Frame: at 6 months ]
  • Drospirenone volume of distribution [ Time Frame: at 6 months ]
  • Drospirenone apparent clearance [ Time Frame: at 6 months ]

Enrollment: 1045
Actual Study Start Date: October 2014
Estimated Study Completion Date: March 15, 2018
Primary Completion Date: October 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LF111 (drospirenone)
single treatment arm receives LF111
Drug: LF111 (drospirenone)
One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
Other Name: CF111

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Sexually active, postmenarcheal and premenopausal female subjects at risk of pregnancy including breastfeeding women with no upper age limit.
  2. 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.
  3. Regular cycles during the last six months before consent/assent when not using hormonal contraception.
  4. 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.
  5. 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.
  6. Be able and willing to provide written informed consent or assent if the subject is adolescent, prior to undergoing any trial-related procedure.
  7. Willing to use trial contraception for thirteen 28-day cycles.
  8. Be willing to have intercourse each cycle of trial without the need to use back-up contraceptive.
  9. 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.
  10. Agree not to participate in any other clinical trials during the course of this trial.

Exclusion Criteria:

  1. Pregnant.
  2. 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.
  3. History of infertility.
  4. Abnormal finding on pelvic, breast or ultrasound examination that in the investigator's opinion contraindicates participation in the trial.
  5. Unexplained amenorrhea.
  6. Known polycystic ovary syndrome.
  7. 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.
  8. Known contraindication or hypersensitivity to ingredients or excipients of the IMP, including:

    1. Renal insufficiency
    2. Hepatic dysfunction
    3. Adrenal insufficiency
    4. Current or history of venous thrombophlebitis or thromboembolic disorders (venous thrombembolism, which includes deep vein thrombosis and pulmonary embolism)
    5. Current or history of cerebral-vascular or coronary-artery disease
    6. Valvular heart disease with thrombogenic complications
    7. Diabetes with vascular involvement
    8. Headaches with focal neurological symptoms
    9. Major surgery with prolonged immobilization
    10. Known or suspected carcinoma of the breast
    11. Known or suspectd sex-steroid sensitive malignancies
    12. Undiagnosed abnormal genital bleeding
    13. Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
    14. Liver tumor (benign or malignant) or active clinically significant liver disease.
  9. Uncontrolled thyroid disorder (i.e., on stable dose of thyroid replacement for less than two months).
  10. Uncontrolled concomitant diseases (i.e., not on a stable treatment dose for at least two months).
  11. Evidence or history of alcohol, medication or drug abuse (within the last 12 months prior to consent/assent).
  12. Known inherited or acquired predisposition to venous thromboembolism or arterial thromboembolism (e.g., factor VLeiden, Prothrombin mutation, Antiphospholipidantibodies) or bruising within the last 12 months prior to consent/assent.
  13. Known or suspected HIV and/or hepatitis infection at screening.
  14. 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.
  15. 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:

    1. Anticonvulsants (e.g. phenytoin, carbamazepine, oxcarbazepine, topiramate, felbamate, primidone)
    2. Barbiturates
    3. Rifampin
    4. Bosentan
    5. Griseofulvin
    6. St. John's wort (hypericum perforatum)
  16. Administration of human chorionic gonadotropin (hCG) or intake of co-medication containing hCG within a month prior to V1b).
  17. Progestin-releasing intra-uterine device (IUD) or contraceptive implant received or in place within the last two months prior to consent/assent.
  18. 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).
  19. Evidence or history of clinically significant psychiatric illness or suicide risk.
  20. 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.
  21. Subject is a member of the investigator's or Sponsor's staff or a relative or family member thereof.
  22. Any condition that, in the opinion of the investigator, may jeopardize protocol compliance or the scientific integrity of the trial.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269241


  Show 36 Study Locations
Sponsors and Collaborators
Laboratories Leon Farma, S.A.
Chemo France
Investigators
Study Director: William Bryant, III Exeltis USA, Inc.
  More Information

Responsible Party: Laboratories Leon Farma, S.A.
ClinicalTrials.gov Identifier: NCT02269241     History of Changes
Other Study ID Numbers: CF111/303
First Submitted: October 6, 2014
First Posted: October 21, 2014
Last Update Posted: November 17, 2017
Last Verified: October 2017

Keywords provided by Chemo ( Laboratories Leon Farma, S.A. ):
contraception
hormonal oral contraceptive agents
hormonal oral contraceptive
oral contraceptive
drospirenone
LF111
birth control

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Drospirenone
Contraceptives, Oral, Hormonal
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents