NCT00320580

Brief Summary

The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

First QC Date

April 28, 2006

Last Update Submit

June 30, 2011

Conditions

Metrorrhagia

Keywords

Metrorrhagiaoral contraceptionbreakthrough bleedingspotting

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.

Secondary Outcomes (1)

  • Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.

Study Arms (1)

001

EXPERIMENTAL

norelgestromin/ethinyl estradiol

Drug: norelgestromin/ethinyl estradiol

Interventions

norelgestromin/ethinyl estradiolDRUG
001

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good health as confirmed by medical history
  • not pregnant as demonstrated by negative urine pregnancy test
  • completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy
  • not lactating
  • post-menarcheal and pre-menopausal

You may not qualify if:

  • History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products
  • treatment with continuous oral contraception within three months of study
  • previous use of contraceptive patch including norelgestromin/ethinyl estradiol
  • patients who are amenorrheic (abnormal suppression or absence of menstruation)
  • recent history of alcohol or substance abuse
  • skin conditions resulting in oily, irritated or damaged skin at potential sites of application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005 Jun;105(6):1389-96. doi: 10.1097/01.AOG.0000160430.61799.f6.

    PMID: 15932834RESULT

  • LaGuardia KD, Fisher AC, Bainbridge JD, LoCoco JM, Friedman AJ. Suppression of estrogen-withdrawal headache with extended transdermal contraception. Fertil Steril. 2005 Jun;83(6):1875-7. doi: 10.1016/j.fertnstert.2004.12.048.

    PMID: 15950671RESULT

MeSH Terms

Conditions

Metrorrhagia

Interventions

norelgestrominEthinyl Estradiol

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 28, 2006

First Posted

May 3, 2006

Study Completion

March 1, 2003

Last Updated

July 1, 2011

Record last verified: 2011-06