NCT01243580

Brief Summary

Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

Trial Health

87
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 Aug 2009

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

December 19, 2017

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

November 16, 2010

Results QC Date

July 21, 2017

Last Update Submit

December 21, 2017

Conditions

Healthy

Keywords

PK and safetyPharmacokinetic profile (PK) and safety

Outcome Measures

Primary Outcomes (13)

  • Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1

    Comparative evaluation of ethinyl estradiol (EE) Cmax between AG200-15 and Ortho-Cyclen® in week 1 for cycle 2 and 3.

    3 months

  • Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3

    Comparative evaluation of EE Cmax between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.

    3 months

  • Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1

    Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3.

    3 months

  • Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3

    Comparative evaluation of EE AUC (0-168hrs post-first dose) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3.

    3 months

  • Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1

    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.

    3 months

  • Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3

    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15 the average concentration within the 48-168 h time-interval was measured.

    3 months

  • Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1

    Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).

    3 months

  • Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3

    Comparative evaluation of EE Css (2) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).

    3 months

  • Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1

    Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).

    3 months

  • Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3

    Comparative evaluation of EE Css (3) between AG200-15 and Ortho-Cyclen® in week 3 for cycles 2 and 3. For Ortho-Cyclen steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For AG200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 0-168h time interval (AUC/time interval).

    3 months

  • Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3

    Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3 for cycles 2 and 3.

    3 months

  • Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3

    Evaluation of LNG AUC (0-168hrs post-first dose) Between AG200-15 in Week 1 and 3 for cycles 2 and 3.

    3 months

  • Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3

    Comparative evaluation of EE Css (1) between AG200-15 and Ortho-Cyclen® in week 1 for cycles 2 and 3. For Ortho-Cyclen, steady-state concentration calculated as average concentration at steady-state from the 24-hour trapezoidal AUC (AUC0-24h/24). For Ag200-15, the average concentration at steady-state calculated from trapezoidal AUC within the 48-168h time interval (AUC/time interval).

    3 months

Study Arms (2)

Ortho-Cyclen®

ACTIVE COMPARATOR

Ortho-Cyclen® is a comparator drug intervention

Drug: Ortho-Cyclen

AG200-15

EXPERIMENTAL

AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention

Drug: AG200-15

Interventions

Ortho-CyclenDRUG

Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.

Also known as: oral contraceptive
Ortho-Cyclen®
AG200-15DRUG

AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Also known as: transdermal contraception
AG200-15

Eligibility Criteria

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

You may qualify if:

  • Healthy women, ages 18-45
  • Body mass index (BMI) ≥18 and ≤32, and weight ≥ 110 lbs.
  • Willing to use a non-hormonal method of contraception if at risk of pregnancy, OR have already undergone previous bilateral tubal ligation or hysterectomy
  • Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior until completion of each treatment period

You may not qualify if:

  • Known or suspected pregnancy;
  • Lactating women
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Miami, Florida, 33169, United States

Location

Related Publications (1)

  • Archer DF, Stanczyk FZ, Rubin A, Foegh M. Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial. Contraception. 2012 Jun;85(6):595-601. doi: 10.1016/j.contraception.2011.10.006. Epub 2011 Nov 30.

    PMID: 22133660DERIVED

MeSH Terms

Interventions

MoxifloxacinContraceptives, Oral

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Results Point of Contact

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

Study Officials

  • Elizabeth Garner, MD, MPH

    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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 23, 2018

Results First Posted

December 19, 2017

Record last verified: 2017-12

Locations

US(1)