Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00511433
First received: August 2, 2007
Last updated: July 28, 2011
Last verified: July 2011
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: NOMAC-E2
Drug: DRSP-EE

  Participant Flow
  Hide Participant Flow

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 6 consecutive 28-day menstrual cycles.
DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 6 consecutive 28-day menstrual cycles.

Participant Flow:   Overall Study
    NOMAC-E2     DRSP-EE  
STARTED     32     16  
COMPLETED     26     15  
NOT COMPLETED     6     1  
Adverse Event                 5                 0  
Other Reason                 1                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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 6 consecutive 28-day menstrual cycles.
DRSP-EE Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol 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 6 consecutive 28-day menstrual cycles.
Total Total of all reporting groups

Baseline Measures
    NOMAC-E2     DRSP-EE     Total  
Number of Participants  
[units: participants]
  32     16     48  
Age  
[units: years]
Mean ± Standard Deviation
  22.8  ± 3.3     22.9  ± 4.3     22.8  ± 3.6  
Gender  
[units: participants]
     
Female     32     16     48  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect on Ovarian Function as Determined by the Number of Participants With an Occurrence of Ovulation   [ Time Frame: Cycle 1, Cycle 2, and Cycle 6 ]

2.  Primary:   Effect on Ovarian Function as Determined by the Maximum Follicle Diameter   [ Time Frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

3.  Primary:   Effect on Ovarian Function as Determined by the Maximum Progesterone Value   [ Time Frame: Screening cycle, Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

4.  Primary:   Effect on Ovarian Function as Determined by 17 Beta-estradiol (E2)   [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

5.  Primary:   Effect on Ovarian Function as Determined by Follicle Stimulating Hormone (FSH)   [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

6.  Primary:   Effect on Ovarian Function as Determined by Luteinizing Hormone (LH)   [ Time Frame: Cycle 1, Cycle 2, Cycle 3, and Cycle 6 ]

7.  Secondary:   Effect on Cervical Mucus as Determined by Insler Score   [ Time Frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 7 (post-treatment cycle) ]

8.  Secondary:   Effect on Maximum Endometrial Thickness   [ Time Frame: Screening Cycle, Cycle 1, Cycle 2, and Cycle 6 ]

9.  Secondary:   Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index)   [ Time Frame: 6 cycles ]

10.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting   [ Time Frame: Every 28-day cycle for 6 cycles ]

11.  Secondary:   Number of Participants With an Occurrence of Absence of Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 6 cycles ]

12.  Secondary:   Number of Participants With an Occurrence of Breakthrough Bleeding   [ Time Frame: Every 28-day cycle for 6 cycles ]

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

14.  Secondary:   Number of Participants With an Occurrence of Early Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 6 cycles ]

15.  Secondary:   Number of Participants With an Occurrence of Continued Withdrawal Bleeding   [ Time Frame: Every 28-day cycle for 5 cycles ]

16.  Secondary:   Average Number of Breakthrough Bleeding/Spotting Days   [ Time Frame: Every 28-day cycle for 6 cycles ]

17.  Secondary:   Average Number of Withdrawal Bleeding Days   [ Time Frame: Every 28-day cycle for 6 cycles ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00511433     History of Changes
Other Study ID Numbers: Organon protocol 292003, P05723
Study First Received: August 2, 2007
Results First Received: July 28, 2011
Last Updated: July 28, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)