Trial Outcomes & Findings for 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) (NCT NCT01044056)
NCT ID: NCT01044056
Last Updated: 2022-02-04
Results Overview
Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
21 days of active treatment and washout period thereafter
Results posted on
2022-02-04
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill
n=8 Participants
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
n=8 Participants
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
n=8 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.6 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 6.59 • n=7 Participants
|
23.1 years
STANDARD_DEVIATION 3.64 • n=5 Participants
|
24.5 years
STANDARD_DEVIATION 5.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 21 days of active treatment and washout period thereafterPopulation: Subjects who received at least one dose of medication
Cmax was measured using ethinylstradiol serum concentration at several time points during the 21 days of active treatment and the washout thereafter.
Outcome measures
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill
n=8 Participants
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
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) (Pharmacokinentic Parameter (PK)) for All Subjects in the Pharmacokinetically Evaluable (ASPE) Group
|
168 pg/ml
Standard Deviation 29.5
|
105 pg/ml
Standard Deviation 12.4
|
37.1 pg/ml
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Subjects who received at least one dose of medication.
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
Outcome measures
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill
n=8 Participants
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
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|---|
|
Area Under the Curve (AUC) 0-21 Days (PK Parameter) Measured for the ASPE Group
|
21.9 nh.h/mL
Standard Deviation 2.9
|
35.8 nh.h/mL
Standard Deviation 5.5
|
10.6 nh.h/mL
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 21 days of active treatment and washout period thereafterPopulation: Subjects who received at least one dose of medication.
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.
Outcome measures
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill
n=8 Participants
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
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|---|
|
AUC 0-tlast (PK Parameter) for the ASPE Group.
|
22.5 ng.h/mL
Standard Deviation 2.9
|
37.5 ng.h/mL
Standard Deviation 5.7
|
11.1 ng.h/mL
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 21 days of active treatment and the washout period thereafterAUC 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.
Outcome measures
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill
n=8 Participants
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
n=6 Participants
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
n=8 Participants
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.
|
|---|---|---|---|
|
AUC 0-infinity (PK Parameter) for the ASPE Group.
|
22.7 ng.h/mL
Standard Deviation 2.8
|
37.7 ng.h/mL
Standard Deviation 5.6
|
11.2 ng.h/mL
Standard Deviation 2.7
|
Adverse Events
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Norelgestrominum and Ethinylestradiol Contraceptive Patch
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets
n=8 participants at risk
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.
|
Norelgestrominum and Ethinylestradiol Contraceptive Patch
n=8 participants at risk
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.
|
Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring
n=8 participants at risk
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
|
|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/8 • 21 days
|
50.0%
4/8 • Number of events 6 • 21 days
|
12.5%
1/8 • Number of events 2 • 21 days
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Gastrointestinal disorders
LOOSE STOOLS
|
0.00%
0/8 • 21 days
|
25.0%
2/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/8 • 21 days
|
37.5%
3/8 • Number of events 6 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
APPLICATION SITE DERMATITIS
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
APPLICATION SITE IRRITATION
|
0.00%
0/8 • 21 days
|
25.0%
2/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
APPLICATION SITE PRURITUS
|
0.00%
0/8 • 21 days
|
37.5%
3/8 • Number of events 4 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
FATIGUE
|
0.00%
0/8 • 21 days
|
37.5%
3/8 • Number of events 3 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
General disorders
VENIPUNCTURE SITE PAIN
|
12.5%
1/8 • Number of events 1 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Immune system disorders
SEASONAL ALLERGY
|
12.5%
1/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/8 • 21 days
|
25.0%
2/8 • Number of events 2 • 21 days
|
25.0%
2/8 • Number of events 2 • 21 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
ANIMAL SCRATCH
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/8 • 21 days
|
37.5%
3/8 • Number of events 3 • 21 days
|
0.00%
0/8 • 21 days
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
Nervous system disorders
HEADACHE
|
12.5%
1/8 • Number of events 1 • 21 days
|
62.5%
5/8 • Number of events 9 • 21 days
|
50.0%
4/8 • Number of events 10 • 21 days
|
|
Nervous system disorders
SYNCOPE VASOVAGAL
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Psychiatric disorders
MOOD ALTERED
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Renal and urinary disorders
URINE ODOUR ABNORMAL
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Reproductive system and breast disorders
BREAST TENDERNESS
|
0.00%
0/8 • 21 days
|
62.5%
5/8 • Number of events 7 • 21 days
|
0.00%
0/8 • 21 days
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/8 • 21 days
|
25.0%
2/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
Reproductive system and breast disorders
GENITAL PAIN
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 2 • 21 days
|
0.00%
0/8 • 21 days
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 4 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
25.0%
2/8 • Number of events 2 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/8 • 21 days
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/8 • 21 days
|
12.5%
1/8 • Number of events 1 • 21 days
|
0.00%
0/8 • 21 days
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place