Clinical Trial: An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen

Brief Summary: The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen

Detailed Summary: This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147
Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Current Primary Outcome: The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.

Original Primary Outcome: Same as current

Current Secondary Outcome: Secondary efficacy variables include the number of bleeding and/or spotting days, number of bleeding days, number of bleeding and/or spotting episodes, and number of bleeding episodes during both treatment regimens

Original Secondary Outcome: Same as current

Information By: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Dates:
Date Received: June 23, 2006
Date Started: November 2003
Date Completion:
Last Updated: March 3, 2011
Last Verified: March 2011