Evaluation of Pharmacodynamic Effects on Ovulation Suppression and Cycle Control of Three Agile Contraceptive Patches Containing Different Doses of Ethinyl Estradiol(EE)During Three Cycles of Administration

This study has been completed.
Sponsor:
Information provided by:
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01250210
First received: November 29, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

The primary objective was to evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs) containing 2 different doses of levonorgestrel (LNG) and 3 different doses of ethinyl estradiol (EE) during 3 consecutive cycles of administration of each treatment.


Condition Intervention Phase
Ovulation Suppression
Drug: levonorgestrel and ethinyl estradiol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Pharmacodynamic Effects on Ovulation Suppression and Cycle Control of Three Agile Contraceptive Patches Containing Different Doses of Ethinyl Estradiol(EE)During Three Cycles of Administration

Resource links provided by NLM:


Further study details as provided by Agile Therapeutics:

Primary Outcome Measures:
  • adequacy of ovulation suppression was the incidence of possible ovulation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • primary cycle control variable was the incidence of Break through Bleeding/Spotting episodes in Cycle 3 [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: September 2007
Study Completion Date: October 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG200-15 Transdermal contraceptive system Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal
Experimental: AG200 Transdermal contraceptive delivery system Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal
Experimental: AG200LE Transdermal contraceptive delivery system Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy adult women, ages 18-45.
  2. Cycles with a usual duration between 21 and 35 days and an individual variation of +/ 3 days.
  3. Normotensive (blood pressure < 140/90 mm Hg at rest) at screening and randomization visits (Visits 1 and 2).
  4. Willing to use a non-hormonal method of contraception for the entire duration of the study, or
  5. Have already undergone previous bilateral tubal ligation OR vasectomized partner OR not at risk of pregnancy.
  6. Willing to refrain from excessive use of alcohol during the entire duration of the study.
  7. Willing to give informed consent to participate in the study.

Exclusion Criteria:

  1. History of significant medical illness or seizures.
  2. Positive hepatitis B or C antibody or positive human immunodeficiency virus (HIV) antibody.
  3. Known or suspected pregnancy.
  4. A recent abnormal cervical smear - low-grade squamous intraepithelial lesion (SIL) or higher in the Bethesda System - which has not been resolved or treated.
  5. Any disorder that contraindicates the use of contraceptive steroids i.e., history of heart attack and stroke, blood clots in the legs, lungs or eyes, history of blood clots in the deep veins of the legs, known or suspected breast cancer, hepatitis or yellowing of the whites of the eyes or the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives, headaches with neurological symptoms, disease of heart valves with complications.
  6. Uncontrolled thyroid disorder.
  7. History of or existing thromboembolic disorder, vascular disease, cerebral vascular, or coronary artery disease.
  8. Undiagnosed abnormal genital bleeding.
  9. Known or suspected breast carcinoma, endometrial carcinoma, or estrogen-dependent neoplasia.
  10. History or presence of dermal hypersensitivity in response to topical application.
  11. Use of an injectable hormonal contraceptive (e.g. Depo-Provera®) within 6 months prior to Day 1.
  12. Use of a contraceptive implant (e.g. Implanon® or Jadelle®) or hormone-medicated intrauterine device within 2 months (60 days) prior to Day 1.
  13. Use of OCs or other sex steroid hormones within 60 days prior to Day 1.
  14. Women who are breast-feeding or are within 2 months of stopping breast-feeding.
  15. Status post-partum or post-abortion within a period of 2 months prior to Day 1.
  16. Chronic use of any medication that might interfere with the metabolism of hormone contraceptives (e.g., rifampin, barbiturates, phenytoin, primidone, topiramate, carbamazepine, phenylbutazone, ritonavir, modafinil, St John's Wort etc.) or use within the past 3 months prior to Day 1.
  17. Administration of investigational drug within 30 days prior to Day 1.
  18. A history (within prior 12 months) of drug or alcohol abuse.
  19. Women who smoke more than 4-5 cigarettes daily.
  20. History of skin sensitivity to adhesives.
  21. Use of over-the-counter medications or herbals that might interfere with the metabolism of hormone contraceptives within 3 days prior to wearing the first patch.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250210

Locations
United States, Arizona
Tuscon, Arizona, United States
United States, California
San Diego, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Pembrook Pines, Florida, United States
Tampa, Florida, United States
United States, Georgia
Sandy Springs, Georgia, United States
United States, North Carolina
Cary, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Tennessee
Bristol, Tennessee, United States
Sponsors and Collaborators
Agile Therapeutics
  More Information

No publications provided

Responsible Party: Lisa Flood, Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01250210     History of Changes
Other Study ID Numbers: ATI-CL11
Study First Received: November 29, 2010
Last Updated: November 29, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Agile Therapeutics:
contraception
pregnancy prevention

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Contraceptive Agents
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on August 28, 2014