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: September 17, 2014
Last verified: September 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.
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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) ]

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
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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).

Serious Adverse Events
    NOMAC-E2     DRSP-EE  
Total, serious adverse events      
# participants affected / at risk     32/1666 (1.92%)     6/554 (1.08%)  
Blood and lymphatic system disorders      
Anaemia 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Cardiac disorders      
Cardiac aneurysm 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Congenital, familial and genetic disorders      
Venous angioma of brain 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Abdominal pain upper 1    
# participants affected / at risk     0/1666 (0.00%)     1/554 (0.18%)  
# events     0     1  
Gastritis 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Hepatobiliary disorders      
Cholecystitis 1    
# participants affected / at risk     2/1666 (0.12%)     0/554 (0.00%)  
# events     2     0  
Cholelithiasis 1    
# participants affected / at risk     5/1666 (0.30%)     0/554 (0.00%)  
# events     5     0  
Infections and infestations      
Appendicitis 1    
# participants affected / at risk     2/1666 (0.12%)     2/554 (0.36%)  
# events     2     2  
Bacterial diarrhoea 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Pneumonia 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Pyelonephritis 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Injury, poisoning and procedural complications      
Ankle fracture 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Femur fracture 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Joint dislocation 1    
# participants affected / at risk     0/1666 (0.00%)     1/554 (0.18%)  
# events     0     1  
Post procedural complication 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Post procedural haemorrhage 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Road traffic accident 1    
# participants affected / at risk     2/1666 (0.12%)     0/554 (0.00%)  
# events     2     0  
Spinal cord injury cervical 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Musculoskeletal and connective tissue disorders      
Back pain 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Benign breast neoplasm 1    
# participants affected / at risk     0/1666 (0.00%)     1/554 (0.18%)  
# events     0     1  
Breast cancer 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Carcinoid tumor of the appendix 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Degeneration of uterine fibroid 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Nervous system disorders      
Migraine 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Optic neuritis 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     2     0  
Pregnancy, puerperium and perinatal conditions      
Premature separation of placenta 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Psychiatric disorders      
Major depression 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Psychotic disorder 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Reproductive system and breast disorders      
Endometriosis 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
Respiratory, thoracic and mediastinal disorders      
Asthmatic crisis 1    
# participants affected / at risk     0/1666 (0.00%)     1/554 (0.18%)  
# events     0     1  
Surgical and medical procedures      
Breast cosmetic surgery 1    
# participants affected / at risk     1/1666 (0.06%)     0/554 (0.00%)  
# events     1     0  
1 Term from vocabulary, MedDRA (11.0)




  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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