Overview

This trial is active, not recruiting.

Condition healthy
Treatment levonorgestrel
Phase phase 1/phase 2
Sponsor Agile Therapeutics
Start date June 2012
End date September 2012
Trial size 36 participants
Trial identifier NCT01623466, ATI-CL21

Summary

Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Evaluate levonorgestrel delivery in AG890-6.5
levonorgestrel
transdermal contraceptive delivery system
(Experimental)
Evaluate levonorgestrel delivery in AG890-12.5
levonorgestrel
transdermal contraceptive delivery system

Primary Outcomes

Measure
Levonorgestrel Pharmacokinetic Profile
time frame: Baseline, 4 weeks and 8 weeks post patch

Secondary Outcomes

Measure
Safety Evaluations
time frame: Baseline to 30 days after last patch

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Body mass index (BMI) greater than or equal to 18. - Willing to use a non-hormonal method of contraception if of childbearing potential, or have already undergone previous bilateral tubal ligation or hysterectomy - Willing to refrain from excessive use of alcohol from 48 hours prior to patch application through completion of the study. Exclusion Criteria: - Known or suspected pregnancy - Lactating women - Status post-partum or post-abortion within a period of 2 months prior to the start of study medication - A cervical cytology smear of Papanicolaou (Pap) class III or greater or a Bethesda System report of low grade squamous intraepithelial lesions (SIL) or greater - Smoking - Hypertension (blood pressure >140 mm Hg systolic and/or >90 mm Hg diastolic) - Valvular heart disease with complications - ECG (in women with BMI ≥35 kg/m2) with clinically significant findings - Diabetes Mellitus - History of headaches with focal neurological symptoms - Uncontrolled thyroid disorder - Sickle cell anemia - Current or history of clinically significant depression in the last year - Known disturbance of lipid metabolism - Acute or chronic hepatocellular disease with abnormal liver function - Hepatic adenoma or carcinoma - Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use - Plans for major surgery - History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease - Undiagnosed abnormal genital bleeding - Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia - History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.) - Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit - Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit - Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit - Chronic use of any medication that might interfere with the efficacy of hormone contraceptives (including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's Wort, topiramate, and HIV protease inhibitors), OR use of these medications within the past 3 months prior to screening visit - A recent history (within prior 2 years ) of drug or alcohol abuse

Additional Information

Official title A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)
Principal investigator Samuel Oberstein, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Agile Therapeutics.