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A Study of Efficacy and Safety With the Transdermal Contraceptive System.

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ClinicalTrials.gov Identifier: NCT00236769
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : November 17, 2010
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Description
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Brief Summary:
The purpose of the study is to evaluate the contraceptive efficacy, safety, cycle control, and compliance with the transdermal contraceptive system.

Condition or disease Intervention/treatment Phase
Contraception Female Contraception Drug: norelgestromin + ethinyl estradiol Phase 3

Detailed Description:
This is an open-label, multicenter, global study to evaluate the contraceptive efficacy, cycle control, safety, compliance and subject satisfaction of the transdermal contraceptive system. Sixteen hundred healthy women will wear the contraceptive patch for either 6 or 13 cycles. The first 530 subjects will wear the patch for 13 cycles, and all subsequent subjects will wear the patch for 6 cycles. At admission Visit 1, study drug (plus 3 reserve patches) and diary cards are dispensed for Cycle 1; first patch application will be on the first day of menses. Study drug and diary cards are dispensed on day 28 of Cycle 1 (Visit 2) for Cycles 2 and 3, on day 28 of Cycle 3 (Visit 3) for Cycles 4 to 6, on day 28 of Cycle 6 (Visit 4) for Cycles 7 to 9, and on day 28 of Cycle 9 (Visit 5) for Cycles10 to13. At each of these visits, diary cards and empty medication packages are collected. Final study visits are on day 28 of Cycles 6 and 13. Diary card information is used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy is assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations are based on adverse events, which are collected throughout the study, and changes in gynecologic examinations, vital signs, and laboratory results from admission to final visit. Each transdermal contraceptive patch, containing 6 mg NGM and 0.75 mg EE, and delivering 250 ug 17-dNGM and 25 ug EE over 24 hours for 7 days, is worn for 1 week and replaced for 3 consecutive weeks. The fourth week is patch-free. The patch can be worn on: upper arm or torso, buttock, or abdomen.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1751 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17deacetyl-norgestimate and Ethinyl Estradiol.
Study Start Date : November 1997
Actual Study Completion Date : October 1999

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Contraceptive efficacy is assessed with the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety is evaluated throughout the study.

Secondary Outcome Measures :
  1. Cycle control and compliance are assessed with diary cards containing bleeding information and dosing information.

Eligibility Criteria
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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:

  • Healthy women with regular menstrual cycles
  • sexually active and at risk of pregnancy
  • nonpregnant
  • acceptable body mass index (BMI)
  • last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
  • sitting BP<140mmHg/<90mmHg
  • 1 normal menstrual cycle since removal of IUD or norplant
  • agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
  • agree not to use other systemic steroid medication

Exclusion Criteria:

  • Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
  • cerebral vascular or coronary artery disease, hypertension, or severe migraines
  • liver tumor resulting from estrogen-containing products
  • diabetes mellitus
  • cholestatic jaundice, liver or renal disease
  • abnormal PAP smear
  • thyroid disorder
  • dermal hypersensitivity
  • carcinoma of breast, endometrium or other estrogen-dependent neoplasia
  • substance abuse
  • received experimental drug within prior 30 days
  • smoking women over 35 years of age.
Contacts and Locations
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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): NCT00236769


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00236769    
Other Study ID Numbers: CR005500
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: November 17, 2010
Last Verified: November 2010
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
contraception
transdermal contraception
hormonal, steroidal contraception
ethinyl estradiol
progesterone
Additional relevant MeSH terms:
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Ethinyl Estradiol
Norelgestromin
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral