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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00413062
First received: December 18, 2006
Last updated: May 20, 2014
Last verified: May 2014
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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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 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) ]

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) ]

3.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

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) ]

5.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

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) ]

7.  Secondary:   Number of Participants With an Occurrence of Early Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

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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Measure Type Secondary
Measure Title Number of Participants With an Occurrence of Continued Withdrawal Bleeding
Measure Description

Cycle control was evaluated on the basis of vaginal bleeding pattern as recorded daily by participants using e-diaries. Participants documented whether vaginal bleeding was present, and if present, indicated whether it was considered to be spotting or bleeding. Continued withdrawal bleeding was defined as any withdrawal bleeding that continued into the "expected non-bleeding period" of the next cycle.

Expected non-bleeding period: DRSP-EE group: 21-day period starting on Day 1 of the cycle; NOMAC-E2: 21-day period starting on Day 4 of the cycle.

Time Frame Every 28-day cycle for 12 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 ITT group consisted of all participants who were treated; ITT analyses of vaginal bleeding patterns were based on all participants in the ITT group who had at least one evaluable cycle. Cycles were considered to be non-evaluable in case of insufficient bleeding data or improper cycle length.

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).

n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined).

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).

n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined).


Measured Values
    NOMAC-E2     DRSP-EE  
Number of Participants Analyzed  
[units: participants]
  1312     436  
Number of Participants With an Occurrence of Continued Withdrawal Bleeding  
[units: participants]
   
Cycle 1 (n=1179 NOMAC-E2; n=393 DRSP-EE)     367     216  
Cycle 2 (n=939 NOMAC-E2; n=304 DRSP-EE)     309     174  
Cycle 3 (n=794 NOMAC-E2; n=254 DRSP-EE)     225     149  
Cycle 4 (n=730 NOMAC-E2; n=235 DRSP-EE)     192     145  
Cycle 5 (n=659 NOMAC-E2; n=227 DRSP-EE)     171     135  
Cycle 6 (n=617 NOMAC-E2; n=207 DRSP-EE)     149     122  
Cycle 7 (n=555 NOMAC-E2; n=194 DRSP-EE)     142     111  
Cycle 8 (n=540 NOMAC-E2; n=188 DRSP-EE)     128     107  
Cycle 9 (n=503 NOMAC-E2; n=171 DRSP-EE)     116     106  
Cycle 10 (n=486 NOMAC-E2; n=169 DRSP-EE)     121     95  
Cycle 11 (n=455 NOMAC-E2; n=159 DRSP-EE)     90     94  
Cycle 12 (n=421 NOMAC-E2; n=149 DRSP-EE)     95     78  

No statistical analysis provided for Number of Participants With an Occurrence of Continued Withdrawal Bleeding



9.  Secondary:   Average Number of Breakthrough Bleeding/Spotting Days   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]

10.  Secondary:   Average Number of Withdrawal Bleeding/Spotting Days   [ Time Frame: Every 28-day cycle for 13 cycles (one year total) ]


  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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