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Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea (Dysmenorrhea)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00517556
First received: May 18, 2007
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: January 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: CCOCP
Drug: Traditional OCP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Study Group (CCOCP) treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
Control Group (Traditional OCP) 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.

Participant Flow:   Overall Study
    Study Group (CCOCP)   Control Group (Traditional OCP)
STARTED   19   19 
COMPLETED   15   14 
NOT COMPLETED   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Study Group (CCOCP) treatment with monophasic oral contraceptive (gestodene 0,075 mg /ethinyl estradiol 20 mcg) for 168 continuous days through six cycles
Control Group (Traditional OCP) 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 Total of all reporting groups

Baseline Measures
   Study Group (CCOCP)   Control Group (Traditional OCP)   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.47  (3.91)   21.00  (4.03)   20.74  (3.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      19 100.0%      19 100.0%      38 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Croatia   19   19   38 
BMI 
[Units: Kg/m^2]
Mean (Standard Deviation)
 21.20  (3.23)   20.36  (1.77)   20.78  (2.60) 


  Outcome Measures

1.  Primary:   Change in Visual Analog Scale (VAS) Score   [ Time Frame: Baseline and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard S. Legro, M.D.
Organization: The Milton S. Hershey Medical Center
phone: 717-531-6210
e-mail: rsl1@psu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Richard S. Legro, M.D., Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00517556     History of Changes
Other Study ID Numbers: 25239
Study First Received: May 18, 2007
Results First Received: January 26, 2017
Last Updated: March 20, 2017