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A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01670656
First received: August 14, 2012
Last updated: July 25, 2017
Last verified: July 2017
Results First Received: July 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Dysmenorrhea
Interventions: Drug: Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)
Drug: Etonogestrel containing contraceptive vaginal ring (ENG-CVR)
Drug: Placebo
Drug: Ibuprofen

  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
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
NOMAC-E2 700/300 mcg NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
NOMAC-E2 900/300 mcg NOMAC-E2 900/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 100/300 mcg ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 125/300 mcg ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Placebo Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.

Participant Flow:   Overall Study
    NOMAC-E2 700/300 mcg   NOMAC-E2 900/300 mcg   ENG-E2 100/300 mcg   ENG-E2 125/300 mcg   Placebo
STARTED   86   91   87   85   90 
Treated   86   91   86   85   90 
COMPLETED   83   84   79   79   79 
NOT COMPLETED   3   7   8   6   11 
Non-compliance with study drug                0                0                3                0                1 
Pregnancy                0                0                0                0                1 
Withdrawal by Subject                1                1                0                0                0 
Non-compliance with protocol                0                3                1                1                2 
Adverse Event                2                2                2                3                3 
Subject withdrew consent                0                1                2                1                1 
Lost to Follow-up                0                0                0                0                3 
Subject moved                0                0                0                1                0 



  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.
No text entered.

Reporting Groups
  Description
NOMAC-E2 700/300 mcg NOMAC-E2 700/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
NOMAC-E2 900/300 mcg NOMAC-E2 900/300 mcg administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 100/300 mcg ENG-E2 100/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
ENG-E2 125/300 mcg ENG-E2 125/300 mcg was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Placebo Placebo was administered for two 28-day treatment periods, each period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
Total Total of all reporting groups

Baseline Measures
   NOMAC-E2 700/300 mcg   NOMAC-E2 900/300 mcg   ENG-E2 100/300 mcg   ENG-E2 125/300 mcg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   91   87   85   90   439 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.7  (7.5)   28.7  (8.1)   29.0  (7.7)   28.3  (7.8)   28.4  (8.2)   28.6  (7.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      86 100.0%      91 100.0%      87 100.0%      85 100.0%      90 100.0%      439 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2   [ Time Frame: Baseline and Day 29 to 56 (Cycle 2) ]

2.  Secondary:   Change From Baseline in Total Mean Impact Score Through Cycle 2   [ Time Frame: Baseline and Day 29 to 56 (Cycle 2) ]

3.  Secondary:   Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2   [ Time Frame: Baseline and Day 29 to 56 (Cycle 2) ]

4.  Secondary:   Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2   [ Time Frame: Baseline and Day 29 to 56 (Cycle 2) ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01670656     History of Changes
Other Study ID Numbers: P08257
2012-002449-40 ( EudraCT Number )
MK-8175A/MK-8342B-057 ( Other Identifier: Merck )
Study First Received: August 14, 2012
Results First Received: July 25, 2017
Last Updated: July 25, 2017