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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00413062
First received: December 18, 2006
Last updated: August 26, 2015
Last verified: August 2015
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 
Overall Participants Analyzed 
[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 ]

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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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).

Other Adverse Events
    NOMAC-E2   DRSP-EE
Total, other (not including serious) adverse events     
# participants affected / at risk   720/1666 (43.22%)   162/554 (29.24%) 
Investigations     
Weight increased     
# participants affected / at risk   210/1666 (12.61%)   38/554 (6.86%) 
# events   215   38 
Nervous system disorders     
Headache     
# participants affected / at risk   121/1666 (7.26%)   46/554 (8.30%) 
# events   162   69 
Reproductive system and breast disorders     
Cervical dysplasia     
# participants affected / at risk   77/1666 (4.62%)   34/554 (6.14%) 
# events   78   35 
Metrorrhagia     
# participants affected / at risk   102/1666 (6.12%)   17/554 (3.07%) 
# events   120   18 
Withdrawal bleeding irregular     
# participants affected / at risk   154/1666 (9.24%)   3/554 (0.54%) 
# events   293   6 
Skin and subcutaneous tissue disorders     
Acne     
# participants affected / at risk   327/1666 (19.63%)   60/554 (10.83%) 
# events   390   69 
1 Term from vocabulary, MedDRA (11.0)



  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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