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

December 21, 2017 updated by: Agile Therapeutics

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AG890-6.5
Evaluate levonorgestrel delivery in AG890-6.5
Drug: levonorgestrel
transdermal contraceptive delivery system
Other Names:
  • patch, transdermal contraceptive delivery system
Experimental: AG890-12.5
Evaluate levonorgestrel delivery in AG890-12.5
Drug: levonorgestrel
transdermal contraceptive delivery system
Other Names:
  • patch, transdermal contraceptive delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levonorgestrel Pharmacokinetic Profile
Time Frame: 8 weeks
The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.
8 weeks
Evaluation of Patch Adhesion
Time Frame: 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
8 weeks
Evaluation of Irritation at Patch Application Site
Time Frame: 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
8 weeks
Evaluation of Itching at Patch Application Site
Time Frame: 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
8 weeks
Cycle Control
Time Frame: 8 weeks
Measurement of unscheduled bleeding/spotting days.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agile Therapeutics

Investigators

  • Study Director: Elizabeth Garner, MD, PHD, Agile Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI-CL21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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