Clinical trial NCT01623466: Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: PK and Safety
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Levonorgestrel Pharmacokinetic Profile
timeFrame: 8 weeks
measure: Evaluation of Patch Adhesion
timeFrame: 8 weeks
measure: Evaluation of Irritation at Patch Application Site
timeFrame: 8 weeks
measure: Evaluation of Itching at Patch Application Site
timeFrame: 8 weeks
measure: Cycle Control
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, PHD
role: STUDY_DIRECTOR
References: