ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial in Healthy Female Subjects to Compare the Pharmacokinetics of Ethinyl Estradiol of NuvaRing®, a Contraceptive Patch (EVRA(TM)) and an Oral Contraceptive (Microgynon® 30) (Study 34237 (P06650)) (COMPLETED)

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.
ClinicalTrials.gov Identifier: NCT01044056
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : March 31, 2010
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Contraception
Interventions: Drug: Levonorgestrel (LNG)/Ethinylestradiol (EE) oral contraceptive tablets
Drug: norelgestrominum and ethinylestradiol patch oral contraceptive patch
Drug: Nuvaring ™ (etonorgestrel/ethinylestradiol)

  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
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
Norelgestrominum and Ethinylestradiol Contraceptive Patch A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.

Participant Flow:   Overall Study
    Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill   Norelgestrominum and Ethinylestradiol Contraceptive Patch   Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
STARTED   8   8   8 
COMPLETED   8   8   8 
NOT COMPLETED   0   0   0 



  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
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
Norelgestrominum and Ethinylestradiol Contraceptive Patch A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
Total Total of all reporting groups

Baseline Measures
   Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill   Norelgestrominum and Ethinylestradiol Contraceptive Patch   Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.6  (5.44)   24.8  (6.59)   23.1  (3.64)   24.5  (5.24) 
Gender 
[Units: Participants]
       
Female   8   8   8   24 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Netherlands   8   8   8   24 


  Outcome Measures

1.  Primary:   Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group   [ Time Frame: 21 days of active treatment and washout period thereafter ]

2.  Primary:   Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group   [ Time Frame: 21 days ]

3.  Primary:   AUC 0-tlast (PK Parameter) for the ASPE Group.   [ Time Frame: 21 days of active treatment and washout period thereafter ]

4.  Primary:   AUC 0-infinity (PK Parameter) for the ASPE Group.   [ Time Frame: 21 days of active treatment and the washout period thereafter ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01044056     History of Changes
Other Study ID Numbers: P06650
First Submitted: January 5, 2010
First Posted: January 7, 2010
Results First Submitted: February 11, 2010
Results First Posted: March 31, 2010
Last Update Posted: July 1, 2015