Clinical trial NCT00338052: Study of Bleeding With Extended Administration of an Oral Contraceptive
Official title: Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Contraception
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-06-20
Enrollment: 207
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an non-comparative study. There is no statistical hypothesis. The effects of extension of treatment on bleeding will be recorded and described.


Eligibility criteria: Inclusion Criteria:

* Healthy women
* Age 25-40
* History of regular cycles

Exclusion Criteria:

* Current or recent (within 2 months) users of hormonal contraceptives
* Contraindications for use of hormonal contraception
* Conditions which affect the absorption or metabolism of steroid hormones
* BMI \> 35

Primary outcomes:
measure: Number of bleeding/spotting days/episodes per treatment cycle
Secondary outcomes:
measure: Satisfaction
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Boynton Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Leesburg
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Decatur
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Peoria
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Warner Chilcott Investigational Site
state: Kentucky
city: New Bern
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Pleasant Grove
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Sandy
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Virginia Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Sponsor GmbH
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: