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Trial record 19 of 25 for:    gestodene

Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (Dysmenorrhea)

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: NCT00517556
Recruitment Status : Completed
First Posted : August 17, 2007
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Dysmenorrhea
Interventions Drug: CCOCP
Drug: Traditional OCP
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Group (CCOCP) Control Group (Traditional OCP)
Hide Arm/Group Description treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
Period Title: Overall Study
Started 19 19
Completed 15 14
Not Completed 4 5
Arm/Group Title Study Group (CCOCP) Control Group (Traditional OCP) Total
Hide Arm/Group Description treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles. Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 19 participants 38 participants
20.47  (3.91) 21.00  (4.03) 20.74  (3.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
19
 100.0%
19
 100.0%
38
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Croatia Number Analyzed 19 participants 19 participants 38 participants
19 19 38
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 19 participants 38 participants
21.20  (3.23) 20.36  (1.77) 20.78  (2.60)
1.Primary Outcome
Title Change in Visual Analog Scale (VAS) Score
Hide Description Change in subjective perception of pain, as measured by the VAS. Subjects completed the VAS at baseline and 6 months. The VAS ranges from 0 (no pain) to 100 (worst pain). Therefore, a negative change in VAS indicates improvement in pain and a positive change in VAS indicates worsening of pain.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group (CCOCP) Control Group (Traditional OCP)
Hide Arm/Group Description:
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
Overall Number of Participants Analyzed 19 19
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-74.8
(-86.1 to -63.5)
-58.7
(-70.3 to -47.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group (CCOCP), Control Group (Traditional OCP)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group (CCOCP) Control Group (Traditional OCP)
Hide Arm/Group Description treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for traditional (21 active days/7 inactive days) regimen through six cycles.
All-Cause Mortality
Study Group (CCOCP) Control Group (Traditional OCP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Study Group (CCOCP) Control Group (Traditional OCP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Study Group (CCOCP) Control Group (Traditional OCP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/19 (0.00%) 
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: Richard S. Legro, M.D.
Organization: The Milton S. Hershey Medical Center
Phone: 717-531-6210
EMail: rsl1@psu.edu
Layout table for additonal information
Responsible Party: Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00517556    
Other Study ID Numbers: 25239
First Submitted: May 18, 2007
First Posted: August 17, 2007
Results First Submitted: January 26, 2017
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017