Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control

July 3, 2018 updated by: Agile Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
    • California
      • San Diego, California, United States, 92108
    • Colorado
      • Denver, Colorado, United States, 80218
    • Florida
      • Pembroke Pines, Florida, United States, 33026
      • Tampa, Florida, United States, 33607
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Winston-Salem, North Carolina, United States, 27103
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19114
    • Tennessee
      • Bristol, Tennessee, United States, 37620

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agile Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

February 1, 2008

Study Completion (ACTUAL)

February 1, 2008

Study Registration Dates

First Submitted

November 29, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (ESTIMATE)

November 30, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI-CL11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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