Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 30 of 101 for:    ETHINYL ESTRADIOL AND DROSPIRENONE

The Oral Contraceptive Pill for Premenstrual Worsening of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00633360
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Premenstrual Syndrome
Depression
Interventions Drug: Drospirenone and ethinyl estradiol
Drug: Placebo
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drospirenone and Ethinyl Estradiol Placebo
Hide Arm/Group Description

Drospirenone and ethinyl estradiol

Drospirenone and ethinyl estradiol: Once daily by mouth

Placebo

Placebo: Once daily by mouth

Period Title: Overall Study
Started 16 16
Completed 12 13
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             1             1
Adverse Event             3             1
Protocol Violation             0             1
Arm/Group Title Drospirenone and Ethinyl Estradiol Placebo Total
Hide Arm/Group Description

Drospirenone and ethinyl estradiol

Drospirenone and ethinyl estradiol: Once daily by mouth

Placebo

Placebo: Once daily by mouth

Total of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 16 participants 32 participants
28.1  (7.3) 26.3  (7.1) 27.2  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
16
 100.0%
16
 100.0%
32
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score.
Time Frame Baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drospirenone and Ethinyl Estradiol Placebo
Hide Arm/Group Description:

Drospirenone and ethinyl estradiol

Drospirenone and ethinyl estradiol: Once daily by mouth

Placebo

Placebo: Once daily by mouth

Overall Number of Participants Analyzed 12 13
Median (Inter-Quartile Range)
Unit of Measure: percent change
-43.6
(-73.8 to -24.6)
-38.9
(-61.5 to 0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drospirenone and Ethinyl Estradiol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change in Daily Record of Severity of Problems (DRSP)
Hide Description The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden.
Time Frame Baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drospirenone and Ethinyl Estradiol Placebo
Hide Arm/Group Description:
Drospirenone and ethinyl estradiol
Placebo
Overall Number of Participants Analyzed 12 13
Median (Inter-Quartile Range)
Unit of Measure: percent change
-23.5
(-38.4 to -7.0)
-20.9
(-38.7 to -11.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Drospirenone and Ethinyl Estradiol, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Drospirenone and Ethinyl Estradiol Placebo
Hide Arm/Group Description

Drospirenone and ethinyl estradiol

Drospirenone and ethinyl estradiol: Once daily by mouth

Placebo

Placebo: Once daily by mouth

All-Cause Mortality
Drospirenone and Ethinyl Estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Drospirenone and Ethinyl Estradiol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/16 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Drospirenone and Ethinyl Estradiol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/16 (62.50%)      7/16 (43.75%)    
Gastrointestinal disorders     
nausea  1/16 (6.25%)  1 3/16 (18.75%)  3
Nervous system disorders     
headache  2/16 (12.50%)  2 3/16 (18.75%)  3
Reproductive system and breast disorders     
spotting  8/16 (50.00%)  8 1/16 (6.25%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Hadine Joffe
Organization: Brigham & Women's Hospital
Phone: 617-732-4906
EMail: hjoffe@partners.org
Layout table for additonal information
Responsible Party: Hadine Joffe, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00633360     History of Changes
Other Study ID Numbers: 2007-P-002057
First Submitted: March 4, 2008
First Posted: March 12, 2008
Results First Submitted: June 24, 2016
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017