Clinical trial NCT00195559: Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric Disorder
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Syndrome
Menstruation Disturbances
Keywords: Premenstrual Syndrome (PMS)
Hormone Therapy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 526
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
Secondary outcomes:
measure: Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma de Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Rosario-Santa Fe
country: Argentina
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Santiago
country: Chile
city: Temuco
country: Chile
city: Arhus
country: Denmark
city: Frederiksberg
country: Denmark
city: Kobenhavn NV
country: Denmark
city: Rungsted Kyst
country: Denmark
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Turku
country: Finland
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Lomas de Virreyes
country: Mexico
state: D.f.
city: Guadalajara
country: Mexico
state: Jalisco
city: Zapopan
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: N.l.
city: San Luis Potosi
country: Mexico
state: SLP
city: Mexico City
country: Mexico
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Den Helder
country: Netherlands
city: Enschede
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Myslowice
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Bucuresti
country: Romania
facility: S
city: Cluj-Napoca
country: Romania
city: Iasi
country: Romania
city: Goteborg
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Conwell
country: United Kingdom
city: Fowey
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: St. Austell
country: United Kingdom
Study officials:
affiliation: For Argentina, Chile, scheima@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, Finland, Sweden, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Mexico, gomezlj@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Managersp
role: PRINCIPAL_INVESTIGATOR
affiliation: For Romania, WPVIMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: