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Efficacy and Safety Study of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292002)(COMPLETED)(P05722)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00413062
First received: December 18, 2006
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
Results First Received: April 27, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: NOMAC-E2
Drug: DRSP-EE

  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
This study recruited participants from North America and South America

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total, 2281 participants were randomized (NOMAC-E2 n=1710; DRSP-EE n=571) but 2220 participants were treated (NOMAC-E2 n=1666; DRSP-EE n=554).

Reporting Groups
  Description
NOMAC-E2 Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).

Participant Flow:   Overall Study
    NOMAC-E2     DRSP-EE  
STARTED     1666     554  
COMPLETED     988     344  
NOT COMPLETED     678     210  
Adverse event/serious adverse event                 289                 56  
Pre-treatment (serious) adverse event                 1                 0  
Withdrawal of informed consent                 111                 36  
Pregnancy                 15                 5  
Pregnancy wish                 17                 6  
Lost to Follow-up                 175                 73  
Other reason                 70                 34  



  Baseline Characteristics
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Reporting Groups
  Description
NOMAC-E2 Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
Total Total of all reporting groups

Baseline Measures
    NOMAC-E2     DRSP-EE     Total  
Number of Participants  
[units: participants]
 		  1666     554     2220  
Age  
[units: years]
Mean ± Standard Deviation 		  27.6  ± 7.2     27.8  ± 7.0     27.7  ± 7.1  
Gender  
[units: participants]
 		     
Female     1666     554     2220  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)   [ Time Frame: 1 year (13 cycles) ]
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Measure Type Primary
Measure Title Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)
Measure Description In-treatment pregnancies were pregnancies with an estimated date of conception from the day of first intake of trial medication up to and including the day of last (active or placebo) intake of trial medication extended with a maximum of two days. Each 13 cycles (28 days per cycle) of exposure constitutes a woman year. The Pearl Index was obtained by dividing the number of in-treatment pregnancies that occurred by the time (in 100 women years) that the women were under risk of becoming pregnant.
Time Frame 1 year (13 cycles)  
Safety Issue No  

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.
The "restricted ITT" set included all participants treated except for 27 nonpregnant participants whose exposure was excluded due to limited credibility of diary data, & also excluded nonpregnant participants without >= 1 cycle expected to be at risk for pregnancy (with recorded use of condoms or w/o sexual intercourse, based on e-diary data).

Reporting Groups
  Description
NOMAC-E2 Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).

Measured Values
    NOMAC-E2     DRSP-EE  
Number of Participants Analyzed  
[units: participants]
 		  1370     444  
Number of woman years (rounded to nearest integer) Analyzed  
[units: woman years (rounded to nearest integer)]
 		  684     233  
Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)  
[units: Pregnancies per 100 woman years]
Number ( 95% Confidence Interval ) 		   
Overall group     1.754  
  ( 0.9061 to 3.0632 )   		  3.005  
  ( 1.2082 to 6.1917 )  
=<35 years old (n=1158; n=378)     1.963  
  ( 0.9798 to 3.5119 )   		  3.092  
  ( 1.1347 to 6.7299 )  
>35 years old (n=212; n=66)     0.807  
  ( 0.0204 to 4.4977 )   		  2.572  
  ( 0.0651 to 14.33 )  

No statistical analysis provided for Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)



2.  Primary:   Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index)   [ Time Frame: 1 year (13 cycles) ]
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3.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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4.  Secondary:   Number of Participants With an Occurrence of Absence of Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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5.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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6.  Secondary:   Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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7.  Secondary:   Number of Participants With an Occurrence of Early Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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8.  Secondary:   Number of Participants With an Occurrence of Continued Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 12 cycles ]
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9.  Secondary:   Average Number of Breakthrough Bleeding/Spotting Days   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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10.  Secondary:   Average Number of Withdrawal Bleeding/Spotting Days   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]
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  Serious Adverse Events
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  Other Adverse Events
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  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.


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.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00413062     History of Changes
Other Study ID Numbers: Organon protocol 292002, P05722
Study First Received: December 18, 2006
Results First Received: April 27, 2011
Last Updated: March 27, 2013
Health Authority: United States: Food and Drug Administration