HealthyPhase 1NCT01422135
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
A Phase 1 study testing AG200-15 in people with Healthy, run by Agile Therapeutics at 2 sites in United States.
Trial summary
This is a pharmacokinetics and safety study over 3 weekly applications. 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
- 2 sitesUnited States
- Study dates
- Feb 2011to Apr 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 years
- Body mass index 18 - 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
- Hemoglobin within normal range.
Who cannot join
- Known or suspected pregnancy
- 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)
- Diabetes Mellitus
- History of headaches with focal neurological symptoms
Show all 10Show fewer
- Current or history of clinically significant depression in the last year
- Acute or chronic hepatocellular disease with abnormal liver function
- History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Lincoln, Nebraska, 68502
Study site
Neptune City, New Jersey, 07753
About this study
Official title: A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers
This is a pharmacokinetics and safety study over 3 weekly applications.
Read the detailed description
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
- Conditions
- Healthy
- Being tested
- AG200-15
- Keywords
- PK and safety, Pharmacokinetic profile (PK) and safety
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
A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
| Study group | Role | What they receive |
|---|---|---|
| Abdomen, Buttock, Upper Torso | Experimental | Patch was placed on abdomen, buttock then the upper torso excluding breast.
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
| Abdomen, Upper Torso, Buttock | Experimental | Patch was placed on abdomen, upper torso excluding breast then the buttock.
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
| Buttock, Abdomen, Upper Torso | Experimental | Patch was placed on the buttock, abdomen, then the upper torso excluding breast.
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
| Buttock, Upper Torso, Abdomen, | Experimental | Patch was placed on the buttock, upper torso excluding breast then the abdomen
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
| Upper Torso, Abdomen, Buttock | Experimental | Patch was placed on the upper torso excluding breast, abdomen then buttock.
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
| Upper Torso, Buttock, Abdomen | Experimental | Patch was place on the upper torso excluding breast, buttock, then abdomen.
Intervention: AG200-15 patch Receives: Drug: AG200-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-State Concentration (Css) (48-168) Profile for LNG
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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 for EE
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2011
- Study completionApr 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
- Randomised
- Intervention model
- Crossover
- 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, Study director, Agile Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422135
- Sponsor's protocol ID
- ATI-CL15
- Status last verified
- Jul 2018
- First submitted
- 19 Aug 2011
- Last updated
- 31 Dec 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 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study of the Agile TCDS AG200-15 Following Weekly Application to Three Anatomical Sites (Abdomen, Buttock and Upper Torso) in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT01422135
- Acronym / sponsor ID
- ATI-CL15
- Conditions
- Healthy
- Keywords
- PK and safety, Pharmacokinetic profile (PK) and safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Agile TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 31 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pharmacokinetics and safety study over 3 weekly applications.
Detailed description
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Abdomen, Buttock, Upper Torso | Experimental | Drug: AG200-15Patch was placed on abdomen, buttock then the upper torso excluding breast. Intervention: AG200-15 patch |
| Abdomen, Upper Torso, Buttock | Experimental | Drug: AG200-15Patch was placed on abdomen, upper torso excluding breast then the buttock. Intervention: AG200-15 patch |
| Buttock, Abdomen, Upper Torso | Experimental | Drug: AG200-15Patch was placed on the buttock, abdomen, then the upper torso excluding breast. Intervention: AG200-15 patch |
| Buttock, Upper Torso, Abdomen, | Experimental | Drug: AG200-15Patch was placed on the buttock, upper torso excluding breast then the abdomen Intervention: AG200-15 patch |
| Upper Torso, Abdomen, Buttock | Experimental | Drug: AG200-15Patch was placed on the upper torso excluding breast, abdomen then buttock. Intervention: AG200-15 patch |
| Upper Torso, Buttock, Abdomen | Experimental | Drug: AG200-15Patch was place on the upper torso excluding breast, buttock, then abdomen. Intervention: AG200-15 patch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy women, ages 18-45 years
- Body mass index 18 - 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 (10 listed)
- Known or suspected pregnancy
- 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)
- Diabetes Mellitus
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 systemA transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | Drug | Abdomen, Buttock, Upper Torso, Abdomen, Upper Torso, Buttock, Buttock, Abdomen, Upper Torso, Buttock, Upper Torso, Abdomen,, Upper Torso, Abdomen, Buttock, Upper Torso, Buttock, Abdomen |
Primary outcome
Steady-State Concentration (Css) (48-168) Profile for LNG
Time frame: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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 for EE
Time frame: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
Time frame: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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.
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
Time frame: 6 weeks
Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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 study director
Agile Therapeutics
2 sites 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 2 sites 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 6 inclusion and 10 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 31 Dec 2018). 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?
Steady-State Concentration (Css) (48-168) Profile for 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 Dec 2018.