Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches (ATI-CL21)

Agile Therapeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Drug: levonorgestrel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01623466

ATI-CL21

Details and patient eligibility

About

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

Full description

To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.

Enrollment

36 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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