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The Oral Contraceptive Pill for Premenstrual Worsening of Depression

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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