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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)

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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)
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 8 8 8
Completed 8 8 8
Not Completed 0 0 0
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
25.6  (5.44) 24.8  (6.59) 23.1  (3.64) 24.5  (5.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
8
 100.0%
8
 100.0%
8
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 8 participants 8 participants 8 participants 24 participants
8 8 8 24
1.Primary Outcome
Title Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
Hide Description Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
Time Frame 21 days of active treatment and washout period thereafter
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one dose of medication
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 8
Mean (Standard Deviation)
Unit of Measure: pg/ml
168  (29.5) 105  (12.4) 37.1  (5.1)
2.Primary Outcome
Title Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
Hide Description AUC 0-21 days was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment
Time Frame 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one dose of medication.
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 8
Mean (Standard Deviation)
Unit of Measure: nh.h/mL
21.9  (2.9) 35.8  (5.5) 10.6  (2.5)
3.Primary Outcome
Title AUC 0-tlast (PK Parameter) for the ASPE Group.
Hide Description AUC 0-tlast was measured using ethinylestradiol serum concentrations using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter.
Time Frame 21 days of active treatment and washout period thereafter
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received at least one dose of medication.
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 8
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
22.5  (2.9) 37.5  (5.7) 11.1  (2.7)
4.Primary Outcome
Title AUC 0-infinity (PK Parameter) for the ASPE Group.
Hide Description AUC 0-infinity was measured using ethinylestradiol serum concentration using a radio-immune assay at several time points during the 21 days of active treatment and the washout period thereafter. AUC 0-infinity was calculated as AUC 0-tlast extrapolated to infinity using the regression line from which t 1/2 was calculated.
Time Frame 21 days of active treatment and the washout period thereafter
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 8 6 8
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
22.7  (2.8) 37.7  (5.6) 11.2  (2.7)
Time Frame 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Hide Arm/Group Description Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days. A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day. Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
All-Cause Mortality
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets Norelgestrominum and Ethinylestradiol Contraceptive Patch Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/8 (62.50%)      8/8 (100.00%)      8/8 (100.00%)    
Gastrointestinal disorders       
ABDOMINAL PAIN  1  0/8 (0.00%)  0 4/8 (50.00%)  6 1/8 (12.50%)  2
DRY MOUTH  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
FLATULENCE  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
LOOSE STOOLS  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
NAUSEA  1  0/8 (0.00%)  0 3/8 (37.50%)  6 1/8 (12.50%)  1
VOMITING  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
General disorders       
APPLICATION SITE DERMATITIS  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
APPLICATION SITE IRRITATION  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
APPLICATION SITE PRURITUS  1  0/8 (0.00%)  0 3/8 (37.50%)  4 0/8 (0.00%)  0
FATIGUE  1  0/8 (0.00%)  0 3/8 (37.50%)  3 0/8 (0.00%)  0
OEDEMA PERIPHERAL  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
VENIPUNCTURE SITE PAIN  1  1/8 (12.50%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Immune system disorders       
SEASONAL ALLERGY  1  1/8 (12.50%)  2 0/8 (0.00%)  0 1/8 (12.50%)  1
Infections and infestations       
NASOPHARYNGITIS  1  0/8 (0.00%)  0 2/8 (25.00%)  2 2/8 (25.00%)  2
UPPER RESPIRATORY TRACT INFECTION  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Injury, poisoning and procedural complications       
ANIMAL SCRATCH  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
ARTHROPOD BITE  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
CONTUSION  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
FALL  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
MUSCLE STRAIN  1  0/8 (0.00%)  0 3/8 (37.50%)  3 0/8 (0.00%)  0
SKIN LACERATION  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  0/8 (0.00%)  0 1/8 (12.50%)  2 0/8 (0.00%)  0
MYALGIA  1  0/8 (0.00%)  0 1/8 (12.50%)  1 1/8 (12.50%)  1
Nervous system disorders       
DIZZINESS  1  0/8 (0.00%)  0 1/8 (12.50%)  2 0/8 (0.00%)  0
HEADACHE  1  1/8 (12.50%)  1 5/8 (62.50%)  9 4/8 (50.00%)  10
SYNCOPE VASOVAGAL  1  1/8 (12.50%)  1 0/8 (0.00%)  0 1/8 (12.50%)  1
Psychiatric disorders       
MOOD ALTERED  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Renal and urinary disorders       
DYSURIA  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
URINE ODOUR ABNORMAL  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Reproductive system and breast disorders       
BREAST TENDERNESS  1  0/8 (0.00%)  0 5/8 (62.50%)  7 0/8 (0.00%)  0
DYSMENORRHOEA  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
GENITAL PAIN  1  0/8 (0.00%)  0 1/8 (12.50%)  2 0/8 (0.00%)  0
MENORRHAGIA  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
PELVIC PAIN  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
VAGINAL DISCHARGE  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
VAGINAL HAEMORRHAGE  1  0/8 (0.00%)  0 1/8 (12.50%)  4 1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders       
PHARYNGOLARYNGEAL PAIN  1  2/8 (25.00%)  2 1/8 (12.50%)  1 0/8 (0.00%)  0
RHINORRHOEA  1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders       
ACNE  1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
ERYTHEMA NODOSUM  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
INGROWING NAIL  1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 7
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
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