Study of Bleeding With Extended Administration of an Oral Contraceptive

Sponsor

Warner Chilcott (Industry)

Overall Status

Completed

CT.gov ID

NCT00338052

Collaborator

(none)

207

Enrollment

Locations

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Norethindrone 1 mg / ethinyl estradiol 20 mcg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

207 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label Study of Cycle Control With Extended Administration of Norethindrone Acetate 1 mg / Ethinyl Estradiol 20 Mcg Oral Tablets

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Number of bleeding/spotting days/episodes per treatment cycle []

Secondary Outcome Measures

Satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warner Chilcott Investigational Site	Phoenix	Arizona	United States	85031
2	Warner Chilcott Investigational Site	Phoenix	Arizona	United States	85050
3	Warner Chilcott Investigational Site	Tempe	Arizona	United States	85283
4	Warner Chilcott Investigational Site	Carmichael	California	United States	95608
5	Warner Chilcott Investigational Site	Boynton Beach	Florida	United States	33437
6	Warner Chilcott Investigational Site	Leesburg	Florida	United States	34748
7	Warner Chilcott Investigational Site	Miami	Florida	United States	33143
8	Warner Chilcott Investigational Site	Miami	Florida	United States	33186
9	Warner Chilcott Investigational Site	West Palm Beach	Florida	United States	33401
10	Warner Chilcott Investigational Site	Decatur	Georgia	United States	30034
11	Warner Chilcott Investigational Site	Roswell	Georgia	United States	30075
12	Warner Chilcott Investigational Site	Peoria	Illinois	United States	61615
13	Warner Chilcott Investigational Site	Lexington	Kentucky	United States	40509
14	Warner Chilcott Investigational Site	Louisville	Kentucky	United States	40291
15	Warner Chilcott Investigational Site	New Bern	North Carolina	United States	28562
16	Warner Chilcott Investigational Site	Winston Salem	North Carolina	United States	27103
17	Warner Chilcott Investigational Site	Philadelphia	Pennsylvania	United States	19114
18	Warner Chilcott Investigational Site	Greenville	South Carolina	United States	29607
19	Warner Chilcott Investigational Site	Pleasant Grove	Utah	United States	84062
20	Warner Chilcott Investigational Site	Salt Lake City	Utah	United States	84017
21	Warner Chilcott Investigational Site	Sandy	Utah	United States	84070
22	Warner Chilcott Investigational Site	Virginia Beach	Virginia	United States	23456
23	Warner Chilcott Investigational Site	Seattle	Washington	United States	98105