Clinical trial NCT01243580: AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol
Official title: An Open-Label Study to Evaluate Pharmacokinetic Profile of Agile TCDS AG200-15 and to Compare Exposure to Ethinyl Estradiol to Oral Contraceptive (Orthocyclen®) in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK and safety
Pharmacokinetic profile (PK) and safety
Lead sponsor: Agile Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-11-18
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).

Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparative Evaluation of Ethinyl Estradiol (EE) Cmax Between AG200-15 and Ortho-Cyclen® in Week 1
timeFrame: 3 months
measure: Comparative Evaluation of EE Cmax Between AG200-15 and Ortho-Cyclen® in Week 3
timeFrame: 3 months
measure: Comparative Evaluation of EE AUC(0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 1
timeFrame: 3 months
measure: Comparative Evaluation of EE AUC (0-168hrs Post-first Dose) Between AG200-15 and Ortho-Cyclen® in Week 3
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 1
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (1) Between AG200-15 and Ortho-Cyclen® in Week 3
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 1
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (2) Between AG200-15 and Ortho-Cyclen® in Week 3
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 1
timeFrame: 3 months
measure: Comparative Evaluation of EE Css (3) Between AG200-15 and Ortho-Cyclen® in Week 3
timeFrame: 3 months
measure: Evaluation of LNG Cmax Between AG200-15 in Week 1 and 3
timeFrame: 3 months
measure: Evaluation of LNG AUC (0-168hrs Post-first Dose) Between AG200-15 in Week 1 and 3
timeFrame: 3 months
measure: Evaluation of LNG Css (1) Between AG200-15 in Week 1 and 3
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
affiliation: Agile Therapeutics
name: Elizabeth Garner, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.