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Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01250210
Recruitment Status : Completed
First Posted : November 30, 2010
Results First Posted : July 5, 2018
Last Update Posted : July 5, 2018
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics

Brief Summary:
Evaluate the adequacy of ovulation suppression, cycle control, and safety of three transdermal contraceptive delivery systems (TCDSs).

Condition or disease Intervention/treatment Phase
Ovulation Suppression Drug: levonorgestrel and ethinyl estradiol Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: AG200-15
Drug intervention with levonorgestrel and ethinyl estradiol : AG200-15 a transdermal contraceptive system containing 2.60 mg of levonorgestrel and 2.30 mg of ethinyl estradiol.
Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal

Experimental: AG200
Drug intervention with levonorgestrel and ethinyl estradiol: AG200 a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.92 of ethinyl estradiol.
Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal

Experimental: AG200LE
Drug intervention with levonorgestrel and ethinyl estradiol: AG200LE a transdermal contraceptive system containing 2.17 mg of levonorgestrel and 1.28 mg of ethinyl estradiol.
Drug: levonorgestrel and ethinyl estradiol
pregnancy prevention
Other Names:
  • contraception
  • hormonal contraception
  • transdermal




Primary Outcome Measures :
  1. Ovulation Suppression in Three Treatment Groups Over 3 Cycles [ Time Frame: 3 months ]

    Ovulation suppression measured by possible ovulation. Possible ovulation is defined as cycles with greatest progesterone level ≥4.7 ng/mL across Cycles 1-3 combined for each Arm/Group. The following four primary analysis datasets are:

    Intent-to-treat (ITT): At least 1 study patch was applied and at least 1 progesterone measurement is available at 1 of the nominal data collection points.

    Complete progesterone: At least 1 study patch was applied and at least 3 progesterone measurements are available across any of the data collection points.

    Perfect compliance: If no patch has been off >1 day and no more than 1 day has elapsed between patch changes.

    Verifiable compliance: is a cycle during which at least 1 study patch was applied and where LNG and EE measurements were available at each of the nominal data collection points of Days 8, 15, and 22, and all values were above the lower detection limit.


  2. Cycle Control [ Time Frame: 3 months ]
    The incidence of breakthrough bleeding (BTB) and/or spotting (S) episodes in Cycle 3 for ITT cycles. A BTB/S episode was defined as any number of days with BTB and/or BTS preceded and followed by at least 2 bleeding-free days.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01250210


Locations
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United States, Arizona
Tucson, Arizona, United States, 85712
United States, California
San Diego, California, United States, 92108
United States, Colorado
Denver, Colorado, United States, 80218
United States, Florida
Pembroke Pines, Florida, United States, 33026
Tampa, Florida, United States, 33607
United States, Georgia
Sandy Springs, Georgia, United States, 30328
United States, North Carolina
Cary, North Carolina, United States, 27518
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Philadelphia, Pennsylvania, United States, 19114
United States, Tennessee
Bristol, Tennessee, United States, 37620
Sponsors and Collaborators
Agile Therapeutics
Investigators
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Study Director: Elizabeth Garner, MD, MPH Agile Therapeutics
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Responsible Party: Agile Therapeutics
ClinicalTrials.gov Identifier: NCT01250210    
Other Study ID Numbers: ATI-CL11
First Posted: November 30, 2010    Key Record Dates
Results First Posted: July 5, 2018
Last Update Posted: July 5, 2018
Last Verified: July 2018
Keywords provided by Agile Therapeutics:
contraception
pregnancy prevention
Additional relevant MeSH terms:
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Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined