Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00910637

Collaborator

(none)

1,502

Enrollment

Locations

Arm

19.4

Actual Duration (Months)

23.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is examining a birth control patch for 13 cycles (1 year).

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: Gestodene/EE Patch (BAY86-5016)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

1502 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Multicenter, Open-label, Uncontrolled Study to Investigate the Efficacy and Safety of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinyl Estradiol and 2.1 mg Gestodene in a 21-day Regimen for 13 Cycles in 1650 Healthy Female Subjects

Actual Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Dec 13, 2010

Actual Study Completion Date :

Dec 13, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Gestodene/EE Patch (BAY86-5016) 55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Gestodene/EE Patch (BAY86-5016)

55 mg ethinyl estradiol & 2.1 mg gestodene, 21 days for 13 cycles

Outcome Measures

Primary Outcome Measures

Occurrence of pregnancy (yes/no) while on treatment [13 treatment cycles each consisting of 28 days and follow-up period of 14 days]

Secondary Outcome Measures

Vital signs [13 treatment cycles each consisting of 28 days]
Physical and gynecological examinations [13 treatment cycles each consisting of 28 days]
Laboratory assessments [13 treatment cycles each consisting of 28 days]
Adverse events (AE monitoring) [13 treatment cycles each consisting of 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Requiring contraception
Normal cervical smear
Maximum age for smokers is 35
History of regular cyclic menstrual periods

Exclusion Criteria:

Pregnancy or lactation
Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
Use of other contraceptive methods than study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35235
2		Glendale	Arizona	United States	85304
3	Precision Trials	Phoenix	Arizona	United States	85032
4	Visions Clinical Research - Tucson	Tucson	Arizona	United States	85712
5		Carmichael	California	United States	95608
6		Pacific Palisades	California	United States	90272
7		Paramount	California	United States	90723
8	Genesis Center for Clinical Research	San Diego	California	United States	92103
9		San Diego	California	United States	92108
10		San Diego	California	United States	92123
11		Santa Ana	California	United States	92705
12		Torrance	California	United States	90502
13		Denver	Colorado	United States	80218
14		Littleton	Colorado	United States	80122
15		New London	Connecticut	United States	06320
16	Visions Clinical Research	Boynton Beach	Florida	United States	33472-2952
17		Jacksonville	Florida	United States	32207
18		Miami	Florida	United States	33186
19		Pembroke Pines	Florida	United States	33024
20	Meridien Research	Saint Petersburg	Florida	United States	33709
21		Atlanta	Georgia	United States	30328
22		Decatur	Georgia	United States	30034
23		Roswell	Georgia	United States	30075
24	Research Associates	Boise	Idaho	United States	83702
25	Rosemark Women Care Specialist	Idaho Falls	Idaho	United States	83404
26		Chicago	Illinois	United States	60612
27		Newburgh	Indiana	United States	47630
28		South Bend	Indiana	United States	46601
29		Marrero	Louisiana	United States	70072
30		Boston	Massachusetts	United States	02118
31		Chaska	Minnesota	United States	55318
32		Lincoln	Nebraska	United States	68510
33		Las Vegas	Nevada	United States	89030
34		Las Vegas	Nevada	United States	89106
35	Office of Dr. R. Garn Mabey, MD	Las Vegas	Nevada	United States	89128
36		Lawrenceville	New Jersey	United States	08648
37		Moorestown	New Jersey	United States	08057
38		Albuquerque	New Mexico	United States	87102
39		New York	New York	United States	10032
40		New Bern	North Carolina	United States	28562
41		Winston-Salem	North Carolina	United States	27103
42		Cincinnati	Ohio	United States	45267-0457
43		Cleveland	Ohio	United States	44122
44		Columbus	Ohio	United States	43213
45	York Clinical Consulting	Oklahoma City	Oklahoma	United States	73120
46		Eugene	Oregon	United States	97401
47		Portland	Oregon	United States	97239-3011
48		Philadelphia	Pennsylvania	United States	19114
49		Pittsburgh	Pennsylvania	United States	15213
50		Warwick	Rhode Island	United States	02886
51		Columbia	South Carolina	United States	29201
52		Mount Pleasant	South Carolina	United States	29464
53		Chattanooga	Tennessee	United States	37404
54		Knoxville	Tennessee	United States	37920
55	Women's Care Center, PLC	Memphis	Tennessee	United States	38119
56		Nashville	Tennessee	United States	37203
57		Nashville	Tennessee	United States	37205
58		Corpus Christi	Texas	United States	78414
59	Practice Research Organization	Dallas	Texas	United States	75230
60	Advances in Health, inc.	Houston	Texas	United States	77030
61	The Woman's Hospital of Texas	Houston	Texas	United States	77054
62		Norfolk	Virginia	United States	23507
63	Women's Clinical Research Center	Seattle	Washington	United States	98105