NCT01623466

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 28, 2017

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2 months

First QC Date

June 18, 2012

Results QC Date

July 26, 2017

Last Update Submit

December 21, 2017

Conditions

Healthy

Keywords

PK and Safety

Outcome Measures

Primary Outcomes (5)

  • Levonorgestrel Pharmacokinetic Profile

    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

    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

    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

    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

    Measurement of unscheduled bleeding/spotting days.

    8 weeks

Study Arms (2)

AG890-6.5

EXPERIMENTAL

Evaluate levonorgestrel delivery in AG890-6.5

Drug: levonorgestrel

AG890-12.5

EXPERIMENTAL

Evaluate levonorgestrel delivery in AG890-12.5

Drug: levonorgestrel

Interventions

levonorgestrelDRUG

transdermal contraceptive delivery system

Also known as: patch, transdermal contraceptive delivery system
AG890-12.5AG890-6.5

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

LevonorgestrelTransdermal Patch

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEquipment and Supplies

Results Point of Contact

Title
Lisa Flood
Organization
Agile Therapeutics
lflood@agiletherapeutics.com
609-683-1880

Study Officials

  • Elizabeth Garner, MD, PHD

    Agile Therapeutics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 23, 2018

Results First Posted

August 28, 2017

Record last verified: 2017-12