Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00195559
• Collaborator: (none)
• Enrollment: 526
• Locations: 52
• Duration (Months): 27
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether Levonorgestrel/Ethinyl Estradiol (LNG/EE) is effective in treating the symptoms of severe Premenstrual Dysphoric Disorder.

Condition or Disease	Intervention/Treatment	Phase
Premenstrual Syndrome; Menstruation Disturbances	Drug: Levonorgestrel/Ethinyl Estradiol	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 526 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of a Combination of Levonorgestrel and Ethinyl Estradiol in a Continuous Daily Regimen in Subjects With Premenstrual Dysphoric Disorder
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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: No

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 exclusion applies.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Buenos Aires		Argentina
2		Ciudad Autonoma de Buenos Aires		Argentina
3		Cordoba		Argentina
4		Rosario-Santa Fe		Argentina
5		Curitiba		Brazil
6		Goiania		Brazil
7		Porto Alegre		Brazil
8		Salvador		Brazil
9		Sao Paulo		Brazil
10		Sorocaba		Brazil
11		Santiago		Chile
12		Temuco		Chile
13		Arhus		Denmark
14		Frederiksberg		Denmark
15		Kobenhavn NV		Denmark
16		Rungsted Kyst		Denmark
17		Helsinki		Finland
18		Kuopio		Finland
19		Oulu		Finland
20		Turku		Finland
21		Berlin		Germany
22		Bonn		Germany
23		Hamburg		Germany
24		Hannover		Germany
25		Lomas de Virreyes	D.f.	Mexico
26		Guadalajara	Jalisco	Mexico
27		Zapopan	Jalisco	Mexico
28		Monterrey	N.l.	Mexico
29		San Luis Potosi	SLP	Mexico
30		Mexico City		Mexico
31		Amsterdam		Netherlands
32		Apeldoorn		Netherlands
33		Den Helder		Netherlands
34		Enschede		Netherlands
35		Nieuwegein		Netherlands
36		Bialystok		Poland
37		Gdansk		Poland
38		Myslowice		Poland
39		Poznan		Poland
40		Warszawa		Poland
41	S	Bucuresti		Romania
42		Cluj-Napoca		Romania
43		Iasi		Romania
44		Goteborg		Sweden
45		Stockholm		Sweden
46		Umea		Sweden
47		Uppsala		Sweden
48		Conwell		United Kingdom
49		Fowey		United Kingdom
50		London		United Kingdom
51		Plymouth		United Kingdom
52		St. Austell		United Kingdom

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Trial Manager, For Argentina, Chile, [e-mail]
• Principal Investigator: Trial Manager, For Brazil, [e-mail]
• Principal Investigator: Trial Manager, For Denmark, Finland, Sweden, [e-mail]
• Principal Investigator: Trial Manager, For Germany, [e-mail]
• Principal Investigator: Trial Manager, For Mexico, [e-mail]
• Principal Investigator: Trial Manager, For Netherlands, [e-mail]
• Principal Investigator: Trial Managersp, For Poland, [e-mail]
• Principal Investigator: Trial Manager, For Romania, [e-mail]
• Principal Investigator: Trial Manager, For UK, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00195559
• Other Study ID Numbers: 0858A4-318
• First Posted: Sep 19, 2005
• Last Update Posted: Dec 27, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Premenstrual Syndrome (PMS); Hormone Therapy
• Additional relevant MeSH terms: Premenstrual Syndrome; Menstruation Disturbances; Levonorgestrel; Ethinyl Estradiol; Estradiol

Study Results

No Results Posted as of Dec 27, 2007