Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00128934

Collaborator

(none)

744

Enrollment

Locations

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE) is effective in treating the symptoms of severe premenstrual syndrome (PMS).

Condition or Disease	Intervention/Treatment	Phase
Menstruation Disturbances Premenstrual Syndrome	Drug: levonorgestrel/ethinyl estradiol	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

744 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder

Study Start Date :

Aug 1, 2005

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score []

Secondary Outcome Measures

Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Generally healthy, women aged 18 to 49 years.
History of severe PMS symptoms over the last year, as determined by the investigator.
Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit.

Exclusion Criteria:

Major depressive disorder requiring antidepressant treatment or hospitalization within the last 3 years.
Contraindication to combination oral contraceptives.
Use of antidepressants/anxiolytics within 10 days of screening and for the duration of the study.

Other exclusions apply.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Scottsdale	Arizona	United States	85251
2	Tucson	Arizona	United States	85715
3	Jonesboro	Arkansas	United States	72401
4	Little Rock	Arkansas	United States	72205
5	Carmichael	California	United States	95608
6	Los Angeles	California	United States	90095
7	San Diego	California	United States	92103
8	Denver	Colorado	United States	80202
9	Lakewood	Colorado	United States	80228
10	Longmont	Colorado	United States	80501
11	Middletown	Connecticut	United States	06457
12	New Haven	Connecticut	United States	06510
13	Waterbury	Connecticut	United States	06708
14	Washington	District of Columbia	United States	20037
15	Adventure	Florida	United States	33180
16	Clearwater	Florida	United States	33761
17	Fort Myers	Florida	United States	33916
18	Hialeah	Florida	United States	33016
19	Pembroke Pines	Florida	United States	33024
20	West Palm Beach	Florida	United States	33407
21	Atlanta	Georgia	United States	30328
22	Atlanta	Georgia	United States	30342
23	Savannah	Georgia	United States	31406
24	Boise	Idaho	United States	83712
25	Chicago	Illinois	United States	60631
26	Chicago	Illinois	United States	60634
27	Evansville	Indiana	United States	47714
28	South Bend	Indiana	United States	46601
29	Lexington	Kentucky	United States	40509
30	New Orleans	Louisiana	United States	70114
31	Glen Burnie	Maryland	United States	21061
32	Boston	Massachusetts	United States	02114
33	Pittsfield	Massachusetts	United States	01201
34	Springfield	Massachusetts	United States	01107
35	Brooklyn	New York	United States	11235
36	Buffalo	New York	United States	14214
37	New York City	New York	United States	10021
38	Rochester	New York	United States	14609
39	Fayetteville	North Carolina	United States	28304
40	New Bern	North Carolina	United States	28562
41	Winston-Salem	North Carolina	United States	27103
42	Cincinnati	Ohio	United States	45219
43	Cleveland	Ohio	United States	44122
44	Mogadore	Ohio	United States	44260
45	Oklahoma City	Oklahoma	United States	73112
46	Tulsa	Oklahoma	United States	74135
47	Eugene	Oregon	United States	97401
48	Medford	Oregon	United States	97504
49	Philadelphia	Pennsylvania	United States	19104
50	Philadelphia	Pennsylvania	United States	19114
51	Wexford	Pennsylvania	United States	15090
52	East Providence	Rhode Island	United States	02914
53	Greer	South Carolina	United States	29654
54	Hilton Head Island	South Carolina	United States	29926
55	Nashville	Tennessee	United States	37203
56	Austin	Texas	United States	78756
57	Carrollton	Texas	United States	75010
58	Conroe	Texas	United States	77304
59	San Antonio	Texas	United States	78229
60	Salt Lake City	Utah	United States	84107
61	Sandy	Utah	United States	84070
62	Burlington	Vermont	United States	05401
63	Charlottesville	Virginia	United States	22903
64	Norfolk	Virginia	United States	23502
65	Richmond	Virginia	United States	23230
66	Richmond	Virginia	United States	23233
67	Richmond	Virginia	United States	23294
68	Lakewood	Washington	United States	98499
69	Renton	Washington	United States	98055
70	Edmonton	Alberta	Canada	T6G 2C8
71	Edmonton	Alberta	Canada	T6L 5X8
72	Kelowna	British Columbia	Canada	V1Y 2H4
73	Vancouver	British Columbia	Canada	V6H 3N1
74	Hamilton	Ontario	Canada	L8N 4A6
75	Toronto	Ontario	Canada	M9W 4L6
76	Hull	Quebec	Canada	J9A 1K7
77	MontrÃ©al	Quebec	Canada	H1T 1P6
78	MontrÃ©al	Quebec	Canada	H3A 1A1
79	Pointe-Claire	Quebec	Canada	H9R 4S3
80	Quebec City	Quebec	Canada	G1R 2W8
81	Quebec City	Quebec	Canada	G1S 2L6
82	Shawinigan	Quebec	Canada	G9N 2H6
83	Sherbrooke	Quebec	Canada	J1H 4J6