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Phase 1 Completed N=24 Randomized Basic Science

Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females

Healthy
Source: ClinicalTrials.gov NCT01422135 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Steady-State Concentration (Css) (48-168) Profile for LNG — 1256; 1246; 1384 pg/mL

Summary

This is a pharmacokinetics and safety study over 3 weekly applications.

Outcome Measures

OutcomeResultp-value
PRIMARY
Steady-State Concentration (Css) (48-168) Profile for LNG
1256; 1246; 1384 —
PRIMARY
Steady-State Concentration (Css) (48-168) Profile for EE
35.8; 40.7; 42.3 —
PRIMARY
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG
182; 197; 206 —
PRIMARY
Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE
5.8; 7.12; 6.86 —

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01422135). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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