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



Status:Active, not recruiting
Conditions:Contraception, Contraception
Therapuetic Areas:Reproductive
Healthy:No
Age Range:15 - Any
Updated:1/5/2017
Start Date:October 2014
End Date:October 2017

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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.

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.

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.
We found this trial at
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5920 Saratoga Blvd
Corpus Christi, Texas 78414
361-906-9178
Principal Investigator: Charles D Eubank, Jr, MD, FACOG
Phone: 361-814-2223
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Norfolk, Virginia 23507
Principal Investigator: Thomas D Kimble, MD
Phone: 757-446-8426
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Albuquerque, Utah 87109
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Baltimore, Maryland 21287
Principal Investigator: Anne E Burke, MD, MPH
Phone: 410-550-8506
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Birmingham, Alabama 35235
Principal Investigator: William D Summers, MD
Phone: 205-833-2228
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Bluffton, South Carolina 29910
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Michael A Thomas, MD
Phone: 513-584-1631
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Principal Investigator: Suzanne Kim, MD
Phone: 714-668-1500
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Dallas, Texas 75230
Principal Investigator: Kathryn K Waldrep, MD
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Denver, Colorado 80218
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Draper, Utah 84020
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Houston, Texas 77054
Principal Investigator: Mark A Jacobs, MD
Phone: 713-799-1635
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Idaho Falls, Idaho 83404
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Kalamazoo, Michigan 49009
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New Bern, North Carolina 28562
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North Miami, Florida 33161
Principal Investigator: Steven E Chavoustie, MD,FACOG,CCRP
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227 East 30th Street
NY, New York 10016
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Principal Investigator: Kurt T Barnhart, MD, MSCE
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3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
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Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Winston-Salem, North Carolina 27103
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