Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: levonorgestrel

• Registration Number: NCT01623466
• Lead Sponsor: Agile Therapeutics

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Study Start: 2012-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2017-07-26
• Results First Submitted QC: 2017-07-26
• Results First Posted: 2017-08-28
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AG890-6.5	levonorgestrel	Evaluate levonorgestrel delivery in AG890-6.5
AG890-12.5	levonorgestrel	Evaluate levonorgestrel delivery in AG890-12.5

Primary Outcome Measures

Name	Time	Method
Evaluation of Patch Adhesion	8 weeks	Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale: 0: ≥90% adhered (no lift); 1. ≥75% adhered but \<90% (some edges showing lift); 2. ≥50% adhered but \<75% (half of system lifts off); 3. \<50% (\< half of system lifts off, but undetached); 4. patch completely detached
Evaluation of Irritation at Patch Application Site	8 weeks	Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale: 0: None; 1. Mild; 2. Moderate; 3. Severe
Evaluation of Itching at Patch Application Site	8 weeks	Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0. None; 1. Mild; 2. Moderate; 3. Severe
Cycle Control	8 weeks	Measurement of unscheduled bleeding/spotting days.
Levonorgestrel Pharmacokinetic Profile	8 weeks	The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.