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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236795
First received: October 7, 2005
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

The purpose of the study was to compare the contraceptive efficacy and safety of the transdermal patch to Triphasil.


Condition Intervention Phase
Contraception
Female Contraception
Drug: norelgestromin + ethinyl estradiol; triphasil.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study to Evaluate the Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of 17-deacetylnorgestimate and Ethinyl Estradiol With the Oral Contraceptive Triphasil.

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Contraceptive efficacy of the 2 treatments was estimated by determination of pregnancy rates, using the Pearl Index and life table analysis (cumulative probability of pregnancy). Safety was evaluated throughout the study.

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

Enrollment: 1494
Study Start Date: January 1997
Study Completion Date: March 1999
Detailed Description:

This is an open-label, multicenter, worldwide study to evaluate the contraceptive efficacy, safety, cycle control, compliance, and subject satisfaction of the transdermal patch compared with Triphasil. Fourteen hundred healthy women will receive study medication for either 6 or 13 cycles. The first 33% of subjects (~265 transdermal patch subjects and 200 Triphasil subjects) will be expected to complete 13 cycles of medication. All subsequent subjects will be expected to complete 6 cycles. The ratio of subjects assigned to the transdermal patch arm of the study and to the Triphasil arm will be 4:3. At admission (Visit 1) study drug (plus 3 reserve patches), diary cards and subject instructions for Cycle 1 are dispensed. The first patch will be applied and Triphasil pill will be taken on the first day of menses. Study medication and diary cards will be issued on day 28 of Cycles 1 (Visit 2) and 3 (Visit 3), and those continuing for 13 cycles will receive study drug again (plus 3 reserve patches) on day 28 of Cycles 6 (Visit 4) and 9 (Visit 5). Diary cards and empty medication packages will be collected at every visit. Final visits are on day 28 of Cycles 6 and 9. Diary card information is used to record compliance and bleeding information (to assess cycle control). Contraceptive efficacy was assessed by means of the Pearl Index and life table analysis (gross cumulative probability of pregnancy). Safety evaluations were based on adverse events, which were collected throughout the study, and changes in physical examinations, gynecologic examinations, vital signs, and laboratory results from prestudy to final visit. A transdermal patch, containing 6 mg NGM and 0.75 mg EE, delivering 250 ug NGM 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. A Triphasil pill is taken for 28 consecutive days at the same time each day.

  Eligibility

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

Inclusion Criteria:

  • Healthy, nonpregnant women with regular menstrual cycles
  • sexually active and at risk of pregnancy
  • 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
  • undiagnosed abnormal vaginal bleeding
  • thyroid disorder
  • dermal hypersensitivity
  • carcinoma of breast, genital tract or other estrogen-dependent neoplasia
  • received any depot hormone injection within prior 6 months
  • smoking women over 35 years of age.
  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: NCT00236795

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00236795     History of Changes
Other Study ID Numbers: CR005506
Study First Received: October 7, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
contraception
hormonal contraception
oral contraception
steroid, ethinyl estradiol, horgestimate, levonorgestrel contraception
transdermal.

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Contraceptive Agents
Ethinyl estradiol, levonorgestrel drug combination
Norelgestromin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral

ClinicalTrials.gov processed this record on October 19, 2014