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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):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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.
No text entered.

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

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
No text entered.


  More Information

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
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