HealthyPhase 1NCT01375946
Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers
A Phase 1 study testing AG200-15 in people with Healthy, run by Agile Therapeutics at 1 site in United States.
Trial summary
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AG200-15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women, ages 18-45
- Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
- 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 use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
- Willing to give informed consent to participate in study
Who cannot join
- Known or suspected pregnancy
- Breast-feeding or within 1 month after stopping breast-feeding
- Smokers
- Any disease that may worsen with hormonal treatment
- Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
About this study
Official title: A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.
Read the detailed description
Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.
There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
- Conditions
- Healthy
- Being tested
- AG200-15
- Keywords
- Pharmacokinetic Profile (PK) and Safety, PK analysis of EE and LNG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG200-15Drug
Also called transdermal contraceptive delivery system, patch
There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| AG200-15 location | Experimental | The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna). Receives: Drug: AG200-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)
AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Measured: 6 weeks
AUC(0-168) Profile of Ethinyl Estradiol (EE)
AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Measured: 6 weeks
Steady-state Concentration (Css) (48-168) Profile of LNG
Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Measured: 6 weeks
Css (48-168) Profile of EE
Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Measured: 6 weeks
Secondary outcomes (1)
Patch Adhesion
Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale:
0: >90% adhered (essentially no lift off of the skin)
- >75% adhered but <90% (some edges showing lift)
- >50% adhered but <75% (half of system lifts off)
- <50% (> half of system lifts off, but undetached)
- patch completely detached
Patches were assessed prior to patch removal.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Garner, MD, MPH, Study director, Agile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375946
- Sponsor's protocol ID
- ATI-CL16
- Status last verified
- Jul 2018
- First submitted
- 13 Jun 2011
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic And Wearability Study of the Agile TCDS AG200-15 Following Weekly Application Under Various External Conditions in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT01375946
- Acronym / sponsor ID
- ATI-CL16
- Conditions
- Healthy
- Keywords
- Pharmacokinetic Profile (PK) and Safety, PK analysis of EE and LNG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Agile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Posted 21 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and external conditions of heat, humidity, cold water and exercise.
Detailed description
Normal conditions - average daily living activities, Dry Sauna - 10 minutes at 168.8 - 179.6 degrees Fahrenheit, Whirlpool - 10 minutes at 102.2 - 105.8 degrees Fahrenheit, Treadmill - 20 - 30 minutes at 60-80% max heart rate, Cold Water - 5 - 15 minutes at 71.6 degrees Fahrenheit.
There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AG200-15 location | Experimental | Drug: AG200-15The subject will wear AG200-15 for 7 days and be exposed to one of 5 external conditions (normal, treadmill, cold water, whirlpool, dry sauna). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women, ages 18-45
- Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.
- 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 use of alcohol and grapefruit juice from 48 hours prior to patch application until completion of each treatment period
- Willing to give informed consent to participate in study
Key exclusion criteria (5 listed)
- Known or suspected pregnancy
- Breast-feeding or within 1 month after stopping breast-feeding
- Smokers
- Any disease that may worsen with hormonal treatment
- Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG200-15Also: transdermal contraceptive delivery system, patchThere will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks. | Drug | AG200-15 location |
Primary outcome
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)
Time frame: 6 weeks
AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
AUC(0-168) Profile of Ethinyl Estradiol (EE)
Time frame: 6 weeks
AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Steady-state Concentration (Css) (48-168) Profile of LNG
Time frame: 6 weeks
Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
Css (48-168) Profile of EE
Time frame: 6 weeks
Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.
1 secondary outcome
Patch Adhesion
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Garner, MD, MPH study director
Agile Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG200-15 in people with Healthy, run by Agile Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.