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

NCT00344383 | Completed Phase 2

• 1 other identifier: CR008344
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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

Conditions

Metrorrhagia

Keywords

oral contraceptive; breakthrough bleeding; spotting

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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

Interventions

Norgestimate/Ethinyl Estradiol tablet DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months
• Non-smokers, if between 35 and 45 years of age
• Patients who are not pregnant or lactating
• Had at least one normal menstrual period within 35 days prior to screening
• Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy
• Must be post-menarcheal (have had at least one normal menstrual period) and pre-menopausal (having regular menstrual periods)

You may not qualify if:

• History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products
• carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease
• absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse
• significant depression or psychiatric disease that would result in an unreliable patients
• any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.

Sponsors & Collaborators

• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: lead

MeSH Terms

Conditions

Metrorrhagia

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: November 1, 2003
• Study Completion: July 1, 2004
• Last Updated: March 4, 2011

Record last verified: 2011-03