HealthyPhase 1/2ATI-CL21NCT01623466

Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches

A Phase 1/2 study testing levonorgestrel in people with Healthy, run by Agile Therapeutics.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Pharmacokinetics, safety and wearability in two size patches of AG890 over eight weeks will be evaluated. 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?: levonorgestrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Jul 2012to Sep 2012
Phase: Phase 1/2
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

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.

Who cannot join

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)

Show all 27Show fewer

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
Hepatic adenoma or carcinoma
Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
Plans for major surgery
History of or existing venous and arterial thrombotic and thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease
Undiagnosed abnormal genital bleeding
Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia
History or presence of dermal hypersensitivity in response to topical applications (bandages, surgical tape, etc.)
Use of an injectable hormonal contraceptive within the past 10 months prior to the screening visit
Use of a contraceptive implant or hormone-medicated intrauterine device (IUD) within 1 month prior to the screening visit
Use of oral contraceptives or other sex steroid hormones within 2 months prior to the screening visit
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
A recent history (within prior 2 years ) of drug or alcohol abuse

About this study

Official title: A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)

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

Read the detailed description

To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.

Conditions: Healthy
Being tested: levonorgestrel
Keywords: PK and Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

levonorgestrelDrug
Also called patch, transdermal contraceptive delivery system
transdermal contraceptive delivery system

Study groups in NCT01623466
Study group	Role	What they receive
AG890-6.5	Experimental	Evaluate levonorgestrel delivery in AG890-6.5 Receives: Drug: levonorgestrel
AG890-12.5	Experimental	Evaluate levonorgestrel delivery in AG890-12.5 Receives: Drug: levonorgestrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Levonorgestrel Pharmacokinetic Profile
The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.
Measured: 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
Measured: 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
Measured: 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:
1. None
2. Mild
3. Moderate
4. Severe
Measured: 8 weeks
Cycle Control
Measurement of unscheduled bleeding/spotting days.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Sep 2012

First posted20 Jun 2012 (estimated)
Study startJul 2012
Primary completionSep 2012
Study completionSep 2012

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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01623466
Sponsor's protocol ID: ATI-CL21
Acronym: ATI-CL21
Status last verified: Dec 2017
First submitted: 18 Jun 2012
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Parallel Group Study To Evaluate Pharmacokinetic Profile, Wearability And Safety of Two Progestin-Only Patches Containing Different Doses Of Levonorgestrel (LNG)
ClinicalTrials.gov ID: NCT01623466
Acronym / sponsor ID: ATI-CL21 / ATI-CL21
Conditions: Healthy
Keywords: PK and Safety
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Agile TherapeuticsIndustry (pharma, biotech, devices)
Study start: Jul 2012 (actual)
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 20 Jun 2012 (estimated)
Results: Posted 28 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

To evaluate pharmacokinetic (PK) profile, patch wearability (adhesion and skin irritation), and safety of AG890-6.5 and AG890-12.5 TCDS.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AG890-6.5	Experimental	Drug: levonorgestrelEvaluate levonorgestrel delivery in AG890-6.5
AG890-12.5	Experimental	Drug: levonorgestrelEvaluate levonorgestrel delivery in AG890-12.5

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (27 listed)

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

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
levonorgestrelAlso: patch, transdermal contraceptive delivery systemtransdermal contraceptive delivery system	Drug	AG890-12.5, AG890-6.5

Primary outcome

Levonorgestrel Pharmacokinetic Profile
Time frame: 8 weeks
The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.
Evaluation of Patch Adhesion
Time frame: 8 weeks
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
Evaluation of Irritation at Patch Application Site
Time frame: 8 weeks
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
Evaluation of Itching at Patch Application Site
Time frame: 8 weeks
Self-reported worst skin itching at patch application site by subject using a 4-point scale: 0. None 1. Mild 2. Moderate 3. Severe
Cycle Control
Time frame: 8 weeks
Measurement of unscheduled bleeding/spotting days.

Results and safety

Results posted to the registry on 28 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AG890-6.5	18	17
AG890-12.5	18	18

Primary outcome: Levonorgestrel Pharmacokinetic Profile

Time frame: 8 weeks. Number. Unit: % of subjects below 175 pg/mL

Measure	AG890-6.5 n = 17	AG890-12.5 n = 18
Value	100	83.3

Population analysed: Primary PK population

Primary outcome: Evaluation of Patch Adhesion

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	AG890-6.5 n = 17	AG890-12.5 n = 18
Value	0.41 (1.004)	0.78 (1.517)

Population analysed: Safety population

Primary outcome: Evaluation of Irritation at Patch Application Site

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Score on a scale

Measure	AG890-6.5 n = 18	AG890-12.5 n = 18
Value	0.11 (0.471)	0.06 (0.236)

Population analysed: Safety population

Primary outcome: Evaluation of Itching at Patch Application Site

Time frame: 8 weeks. Mean (Standard Deviation). Unit: Score

Measure	AG890-6.5 n = 18	AG890-12.5 n = 18
Value	0.33 (0.594)	0.39 (0.502)

Population analysed: Safety Population

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AG890-6.5	0 of 18 (0%)	11 of 18 (61.1%)	0 of 18
AG890-12.5	0 of 18 (0%)	9 of 18 (50%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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, PHD study director

Agile Therapeutics

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing levonorgestrel in people with Healthy, run by Agile Therapeutics.

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 3 inclusion and 27 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Aug 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?

Levonorgestrel Pharmacokinetic Profile (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623466.

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 23 Jan 2018.