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Effects on Bone Mineral Density (BMD) of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292005)(P05765)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511342
First Posted: August 3, 2007
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: NOMAC-E2
Drug: LNG-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
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 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 26 consecutive 28-day cycles (2 years).
LNG-EE Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (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 26 consecutive 28-day cycles (2 years).

Participant Flow:   Overall Study
    NOMAC-E2   LNG-EE
STARTED   56   54 
COMPLETED   43   32 
NOT COMPLETED   13   22 
Unacceptable vaginal bleeding                2                1 
Other Adverse Event (AE)/ Serious AE                8                12 
Pregnancy                0                1 
Pregnancy wish                0                1 
Lost to Follow-up                1                5 
Other Reason                2                2 



  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 26 consecutive 28-day cycles (2 years).
LNG-EE Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (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 26 consecutive 28-day cycles (2 years).
Total Total of all reporting groups

Baseline Measures
   NOMAC-E2   LNG-EE   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   54   110 
Age 
[Units: Years]
Mean (Standard Deviation)
 23.0  (3.2)   22.1  (2.0)   22.6  (2.7) 
Gender 
[Units: Participants]
     
Female   56   54   110 
Male   0   0   0 
Baseline Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck [1] 
[Units: Score on a scale]
Mean (Full Range)
     
Lumbar Spine   0.351 
 (-2.30 to 2.70) 
 -0.106 
 (-2.19 to 2.88) 
 0.127 
 (-2.30 to 2.88) 
Femoral Neck   0.321 
 (-1.80 to 2.54) 
 0.035 
 (-2.44 to 2.20) 
 0.181 
 (-2.44 to 2.54) 
[1]

The Z-score measures the distance of the measured Bone Mineral Density (BMD) value from the appropriate normal age matched population mean value in units of standard deviation of this population. The following formula was used:

Z-score= BMD value minus mean (age-matched reference population)/ SD (age-matched reference population).

More negative scores indicate less BMD compared to age matched population, and more positive scores indicate higher BMD compared to age matched population.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Z-scores of the Lumbar Spine (L2-L4) and Femoral Neck   [ Time Frame: Baseline and after cycle 26 (2 years) ]

2.  Secondary:   Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)   [ Time Frame: 2 years (26 cycles) ]

3.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding/ Spotting   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

4.  Secondary:   Number of Participants With an Occurrence of Absence of Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

5.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

6.  Secondary:   Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only)   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

7.  Secondary:   Number of Participants With an Occurrence of Early Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

8.  Secondary:   Number of Participants With an Occurrence of Continued Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) including one week after stopping treatment ]

9.  Secondary:   Average Number of Breakthrough Bleeding-Spotting Days   [ Time Frame: Every 28-day cycle for 26 cycles (2 years total) ]

10.  Secondary:   Average Number of Withdrawal Bleeding-spotting Days   [ Time Frame: Every 28-day cycle for 26 cycles (2 years 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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  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.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00511342     History of Changes
Other Study ID Numbers: P05765
Organon Protocol No. 292005
First Submitted: August 2, 2007
First Posted: August 3, 2007
Results First Submitted: July 28, 2011
Results First Posted: August 29, 2011
Last Update Posted: March 3, 2015