Trial Outcomes & Findings for A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG) (NCT NCT01166412)
NCT ID: NCT01166412
Last Updated: 2026-01-07
Results Overview
The primary endpoint is a subject's incidence of the "Poor" cervical mucus score as determined by the modified Insler score. The cervical mucus score will be based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible modified Insler cervical mucus score of 12 (3, 4). The total modified Insler cervical mucus scores of 0-4, 5-8 and 9-12 will be categorized as "Poor," "Fair" and "Good," respectively.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Dose Level AG1000-6.5
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI 32 kg/m2 - \<40 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI 32 kg/m2 - \<40 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
56
|
48
|
|
Overall Study
NOT COMPLETED
|
5
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)
Baseline characteristics by cohort
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=37 Participants
|
60 Participants
n=56 Participants
|
121 Participants
n=95 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 5.92 • n=37 Participants
|
31.0 years
STANDARD_DEVIATION 7.22 • n=56 Participants
|
30.9 years
STANDARD_DEVIATION 6.57 • n=95 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=37 Participants
|
60 Participants
n=56 Participants
|
121 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=37 Participants
|
60 participants
n=56 Participants
|
121 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Treatment Day 1) through Visit 19 (Treatment Day 79)Population: Only cervical mucus data collected after the first dose of study drug is included.
The primary endpoint is a subject's incidence of the "Poor" cervical mucus score as determined by the modified Insler score. The cervical mucus score will be based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible modified Insler cervical mucus score of 12 (3, 4). The total modified Insler cervical mucus scores of 0-4, 5-8 and 9-12 will be categorized as "Poor," "Fair" and "Good," respectively.
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Number of Subjects With Poor Cervical Mucus Scores During Treatment Period
|
3 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: Subjects that had endometrial thickness measured at the respective timepoints were analyzed
Changes from Baseline in endometrial thickness measured at Visit 1, Visits 3-5, Visits 7-10, Visit 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Changes From Baseline in Endometrial Thickness
Baseline
|
7.68 mm
Standard Deviation 3.243
|
7.90 mm
Standard Deviation 2.792
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 16/Day 64
|
-2.26 mm
Standard Deviation 3.676
|
-3.39 mm
Standard Deviation 3.637
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 1/Day 1
|
-2.94 mm
Standard Deviation 3.885
|
-3.32 mm
Standard Deviation 3.730
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 3/Day 5
|
-2.77 mm
Standard Deviation 3.377
|
-3.15 mm
Standard Deviation 2.936
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 4/Day 8
|
-1.75 mm
Standard Deviation 3.706
|
-2.00 mm
Standard Deviation 3.121
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 5/Day 11
|
-0.71 mm
Standard Deviation 3.239
|
-2.50 mm
Standard Deviation 3.673
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 7/Day 18
|
-0.91 mm
Standard Deviation 4.367
|
-2.16 mm
Standard Deviation 3.216
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 8/Day 22
|
-1.34 mm
Standard Deviation 3.960
|
-2.69 mm
Standard Deviation 3.384
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 9/Day 25
|
-1.97 mm
Standard Deviation 3.834
|
-2.87 mm
Standard Deviation 3.769
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 10/Day 29
|
-2.67 mm
Standard Deviation 3.234
|
-3.26 mm
Standard Deviation 3.413
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 12/Day 36
|
-2.10 mm
Standard Deviation 3.995
|
-3.16 mm
Standard Deviation 3.436
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 13/Day 43
|
-1.67 mm
Standard Deviation 3.837
|
-3.18 mm
Standard Deviation 3.183
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 14/Day 50
|
-1.72 mm
Standard Deviation 4.422
|
-3.24 mm
Standard Deviation 3.456
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 15/Day 57
|
-2.18 mm
Standard Deviation 3.940
|
-3.80 mm
Standard Deviation 3.477
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 17/Day 71
|
-2.08 mm
Standard Deviation 4.175
|
-3.56 mm
Standard Deviation 3.224
|
|
Changes From Baseline in Endometrial Thickness
Change from Baseline to Visit 18/Day 78
|
-1.95 mm
Standard Deviation 3.857
|
-2.84 mm
Standard Deviation 3.526
|
SECONDARY outcome
Timeframe: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: subjects that had patch adhesion assessed during the respective timepoints are included
Patch wearability measured by patch adhesion at Visit 4, Visit 6, Visit 8, Visit 10, Visits 12-18 (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78) based on the following criteria: \> 90% = \> 90% of patch adhered (no lift from skin); \>75% but \< 90% = \> 75% adhered but \< 90% (some edges showing lift from skin); \> 50% but \< 75% = \> 50% adhered but \< 75% (half of patch lifts of skin; \< 50% = \< 50% adherence ( \> half of patch lifts off, but not detached); Patch Off = patch completely detached from skin
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Patch Wearability Based on Patch Adhesion
Visit 4/Day 8: 50-75%
|
1 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 13/Day 43: >90%
|
51 Participants
|
46 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 13/Day 43: 75-90%
|
6 Participants
|
4 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 13/Day 43: 50-75%
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 14/Day 50: 75-90%
|
2 Participants
|
8 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 14/Day 50: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 14/Day 50: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 15/Day 57: >90%
|
51 Participants
|
44 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 15/Day 57: 75-90%
|
5 Participants
|
4 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 15/Day 57: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 15/Day 57: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 15/Day 57: Patch Off
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 16/Day 64: >90%
|
51 Participants
|
43 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 16/Day 64: 75-90%
|
5 Participants
|
4 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 16/Day 64: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 16/Day 64: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 16/Day 64: Patch Off
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 17/Day 71: >90%
|
54 Participants
|
45 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 17/Day 71: 75-90%
|
3 Participants
|
4 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 17/Day 71: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 17/Day 71: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 17/Day 71: Patch Off
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 18/Day 78: >90%
|
53 Participants
|
40 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 18/Day 78: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 18/Day 78: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 18/Day 78: Patch Off
|
0 Participants
|
3 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 4/Day 8: >90%
|
49 Participants
|
50 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 4/Day 8: 75-90%
|
9 Participants
|
7 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 4/Day 8: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 4/Day 8: Patch Off
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 6/Day 15: >90%
|
52 Participants
|
46 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 6/Day 15: 75-90%
|
6 Participants
|
9 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 6/Day 15: 50-75%
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 6/Day 15: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 6/Day 15: Patch Off
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 8/Day 22: >90%
|
54 Participants
|
46 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 8/Day 22: 75-90%
|
4 Participants
|
7 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 8/Day 22: 50-75%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 8/Day 22: <50%
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 8/Day 22: Patch Off
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 10/Day 29: >90%
|
56 Participants
|
44 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 10/Day 29: 75-90%
|
2 Participants
|
8 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 10/Day 29: 50-75%
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 10/Day 29: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 10/Day 29: Patch Off
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 12/Day 36: >90%
|
53 Participants
|
47 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 12/Day 36: 75-90%
|
4 Participants
|
3 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 12/Day 36: 50-75%
|
0 Participants
|
3 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 12/Day 36: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 12/Day 36: Patch Off
|
2 Participants
|
1 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 13/Day 43: <50%
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 13/Day 43: Patch Off
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 14/Day 50: >90%
|
55 Participants
|
42 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 14/Day 50: Patch Off
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Patch Adhesion
Visit 18/Day 78: 75-90%
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12), up to 78 daysPopulation: subjects that had samples collected at the respective timeframes were analyzed
LNG PK at 0, 1, 2, 4, and 6 hours with patch on Day 1 (Visit 1), Day 29 (Visit 5), and Day 78 (Visit 12) after patch removal using Area Under the Curve Mean at each visit. The mean area under the curve represents the amount of LNG in the body at the given timepoint.
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
Day 1/Visit 1
|
322.6247 hr*pg/mL
Standard Deviation 141.24822
|
401.3429 hr*pg/mL
Standard Deviation 200.31346
|
|
LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
Day 29/Visit 5
|
1326.6995 hr*pg/mL
Standard Deviation 1663.88816
|
1997.9708 hr*pg/mL
Standard Deviation 1626.87132
|
|
LNG PK Profiles After the First and Fifth Patches Are Applied and After the Eleventh (Last) Patch is Removed
Day 78/Visit 12
|
945.0963 hr*pg/mL
Standard Deviation 590.16226
|
1303.4188 hr*pg/mL
Standard Deviation 781.29795
|
SECONDARY outcome
Timeframe: Treatment Days 2, 8, 15, 22, 30, 36, 43, 50, 57, 64, 71, 79, 80, 81, 82, and 85, up to 85 daysPopulation: subjects that had samples collected during the respective timepoints were analyzed
Serum LNG measures at Day 2 (Visit 2), Day 8 (Visit 4), Day 15 (Visit 6), Day 22 (Visit 8), Days 30, 36, 43, 50, 57, 64, 71 (Visits 11-17), Days 79, 80, 81, 82, 85 (Visits 19-23)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 64
|
162.538 ng/mL
Standard Deviation 130.8442
|
276.387 ng/mL
Standard Deviation 198.0998
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 71
|
167.253 ng/mL
Standard Deviation 128.7246
|
280.677 ng/mL
Standard Deviation 177.6261
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 79
|
100.182 ng/mL
Standard Deviation 54.7594
|
129.584 ng/mL
Standard Deviation 76.1130
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 80
|
72.311 ng/mL
Standard Deviation 41.8869
|
87.295 ng/mL
Standard Deviation 53.3175
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 81
|
48.481 ng/mL
Standard Deviation 22.9973
|
66.773 ng/mL
Standard Deviation 37.6578
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 82
|
37.506 ng/mL
Standard Deviation 22.2807
|
49.627 ng/mL
Standard Deviation 25.1602
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 85
|
29.554 ng/mL
Standard Deviation 25.5765
|
38.882 ng/mL
Standard Deviation 38.1462
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 43
|
168.591 ng/mL
Standard Deviation 136.0588
|
301.725 ng/mL
Standard Deviation 218.2762
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 50
|
174.454 ng/mL
Standard Deviation 143.7253
|
330.625 ng/mL
Standard Deviation 282.0871
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 57
|
176.129 ng/mL
Standard Deviation 133.7951
|
272.921 ng/mL
Standard Deviation 171.9373
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 2
|
181.489 ng/mL
Standard Deviation 174.4023
|
392.703 ng/mL
Standard Deviation 354.6305
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 8
|
183.140 ng/mL
Standard Deviation 143.5979
|
301.107 ng/mL
Standard Deviation 181.3892
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 15
|
175.092 ng/mL
Standard Deviation 123.0980
|
290.184 ng/mL
Standard Deviation 212.5369
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 22
|
174.769 ng/mL
Standard Deviation 126.9624
|
349.906 ng/mL
Standard Deviation 259.7689
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 30
|
276.579 ng/mL
Standard Deviation 247.4270
|
519.327 ng/mL
Standard Deviation 398.7602
|
|
Single Serum LNG PK Measures at Various Times On-treatment and Post Treatment.
Day 36
|
178.315 ng/mL
Standard Deviation 135.2644
|
309.459 ng/mL
Standard Deviation 320.7415
|
SECONDARY outcome
Timeframe: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 daysPopulation: subjects that had samples collected at the respective timepoints were analyzed
Changes from Baseline (Visit 1) in Estradiol levels measured at Visits 3-10, Visit 12-18, Visit 23 (Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Changes From Baseline in Estradiol Levels
Baseline
|
44.1 pg/mL
Standard Deviation 16.61
|
47.2 pg/mL
Standard Deviation 48.40
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 3/Day 5
|
44.7 pg/mL
Standard Deviation 66.19
|
43.8 pg/mL
Standard Deviation 60.55
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 4/Day 8
|
119.4 pg/mL
Standard Deviation 108.95
|
103.2 pg/mL
Standard Deviation 138.77
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 5/Day 11
|
158.4 pg/mL
Standard Deviation 166.04
|
170.7 pg/mL
Standard Deviation 207.28
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 6/Day 15
|
147.1 pg/mL
Standard Deviation 143.95
|
191.9 pg/mL
Standard Deviation 249.75
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 7/Day 18
|
129.1 pg/mL
Standard Deviation 122.25
|
123.8 pg/mL
Standard Deviation 164.50
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 8/Day 22
|
71.5 pg/mL
Standard Deviation 107.17
|
76.6 pg/mL
Standard Deviation 120.61
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 9/Day 25
|
33.8 pg/mL
Standard Deviation 78.86
|
65.0 pg/mL
Standard Deviation 121.64
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 10/Day 29
|
21.4 pg/mL
Standard Deviation 55.67
|
37.8 pg/mL
Standard Deviation 98.50
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 12/Day 36
|
101.6 pg/mL
Standard Deviation 150.53
|
53.9 pg/mL
Standard Deviation 110.20
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 13/Day 43
|
113.4 pg/mL
Standard Deviation 173.71
|
98.6 pg/mL
Standard Deviation 172.48
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 14/Day 50
|
85.7 pg/mL
Standard Deviation 118.49
|
73.7 pg/mL
Standard Deviation 166.09
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 15/Day 57
|
76.4 pg/mL
Standard Deviation 135.90
|
40.1 pg/mL
Standard Deviation 117.25
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 16/Day 64
|
94.5 pg/mL
Standard Deviation 165.60
|
42.4 pg/mL
Standard Deviation 104.84
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 17/Day 71
|
82.6 pg/mL
Standard Deviation 114.90
|
51.3 pg/mL
Standard Deviation 99.92
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 18/Day 78
|
73.2 pg/mL
Standard Deviation 101.43
|
76.1 pg/mL
Standard Deviation 118.96
|
|
Changes From Baseline in Estradiol Levels
Change from Baseline to Visit 23/Day 85
|
77.1 pg/mL
Standard Deviation 119.08
|
78.0 pg/mL
Standard Deviation 104.52
|
SECONDARY outcome
Timeframe: Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85, up to 85 daysPopulation: subjects that had samples collected at the respective timepoints were analyzed
Changes from Baseline (Visit 1) in LH levels measured at Visits 3-10, Visit 12-18, Visit 23 (Days 0, 5, 8, 11, 15, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, 85)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 4/Day 8
|
3.647 mIU/mL
Standard Deviation 3.9407
|
2.855 mIU/mL
Standard Deviation 3.5869
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 5/Day 11
|
5.306 mIU/mL
Standard Deviation 4.5544
|
3.573 mIU/mL
Standard Deviation 3.3224
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 6/Day 15
|
4.011 mIU/mL
Standard Deviation 15.0705
|
1.759 mIU/mL
Standard Deviation 3.4399
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 7/Day 18
|
0.193 mIU/mL
Standard Deviation 4.0425
|
-0.024 mIU/mL
Standard Deviation 4.3170
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 8/Day 22
|
-0.625 mIU/mL
Standard Deviation 2.6920
|
-0.108 mIU/mL
Standard Deviation 4.0482
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 9/Day 25
|
-0.233 mIU/mL
Standard Deviation 2.5591
|
0.094 mIU/mL
Standard Deviation 3.6229
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 10/Day 29
|
0.071 mIU/mL
Standard Deviation 1.8310
|
0.597 mIU/mL
Standard Deviation 3.8260
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 12/Day 36
|
2.219 mIU/mL
Standard Deviation 4.3152
|
1.377 mIU/mL
Standard Deviation 3.3823
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 13/Day 43
|
1.143 mIU/mL
Standard Deviation 3.1123
|
1.915 mIU/mL
Standard Deviation 6.8802
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 14/Day 50
|
-0.146 mIU/mL
Standard Deviation 2.6963
|
0.918 mIU/mL
Standard Deviation 3.5897
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 15/Day 57
|
0.738 mIU/mL
Standard Deviation 3.6271
|
0.916 mIU/mL
Standard Deviation 3.7356
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 16/Day 64
|
2.835 mIU/mL
Standard Deviation 8.3480
|
2.622 mIU/mL
Standard Deviation 3.8875
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 17/Day 71
|
1.158 mIU/mL
Standard Deviation 3.3195
|
1.512 mIU/mL
Standard Deviation 4.0583
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 23/Day 85
|
2.780 mIU/mL
Standard Deviation 8.988
|
1.416 mIU/mL
Standard Deviation 4.0763
|
|
Changes From Baseline in Luteinizing Hormone Levels
Baseline
|
4.988 mIU/mL
Standard Deviation 1.8540
|
5.272 mIU/mL
Standard Deviation 2.0365
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 3/Day 5
|
2.318 mIU/mL
Standard Deviation 3.1376
|
2.391 mIU/mL
Standard Deviation 2.3369
|
|
Changes From Baseline in Luteinizing Hormone Levels
Change from Baseline to Visit 18/Day 78
|
0.302 mIU/mL
Standard Deviation 4.6718
|
1.335 mIU/mL
Standard Deviation 4.1741
|
SECONDARY outcome
Timeframe: Days 0, 29, 57, 78, 85, up to 85 daysPopulation: subjects that had samples collected at the respective timepoints were analyzed
Changes from Baseline (Visit 1) in FSH levels measured at Visits 10/Day 29, Visit 15/Day 57, Visit 18/Day 78, Visit 23/Day 85
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Changes From Baseline in Follicle-Stimulating Hormone Levels
Baseline
|
6.588 mIU/mL
Standard Deviation 2.1862
|
6.626 mIU/mL
Standard Deviation 2.5115
|
|
Changes From Baseline in Follicle-Stimulating Hormone Levels
Change from Baseline to Visit 10/Day 29
|
-0.928 mIU/mL
Standard Deviation 1.8646
|
-1.368 mIU/mL
Standard Deviation 2.2185
|
|
Changes From Baseline in Follicle-Stimulating Hormone Levels
Change from Baseline to Visit 15/Day 57
|
-1.912 mIU/mL
Standard Deviation 2.6797
|
-1.858 mIU/mL
Standard Deviation 3.1649
|
|
Changes From Baseline in Follicle-Stimulating Hormone Levels
Change from Baseline to Visit 18/Day 78
|
-2.190 mIU/mL
Standard Deviation 2.6875
|
-2.113 mIU/mL
Standard Deviation 3.0552
|
|
Changes From Baseline in Follicle-Stimulating Hormone Levels
Change from Baseline to Visit 23/Day 85
|
-1.035 mIU/mL
Standard Deviation 2.4421
|
-2.003 mIU/mL
Standard Deviation 2.8092
|
SECONDARY outcome
Timeframe: Days 0, 29, 57, 78, 85, up to 85 daysPopulation: subjects that had samples collected at the respective timepoints were analyzed
Changes from Baseline (Visit 1) in SHBG levels measured at Visits 10/Day 29, Visit 15/Day 57, Visit 18/Day 78, Visit 23/Day 85
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Baseline
|
5.407 ug/mL
Standard Deviation 2.5143
|
5.367 ug/mL
Standard Deviation 2.3355
|
|
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Change from Baseline to Visit 10/Day 29
|
-1.243 ug/mL
Standard Deviation 1.2113
|
-1.737 ug/mL
Standard Deviation 1.5096
|
|
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Change from Baseline to Visit 15/Day 57
|
-1.032 ug/mL
Standard Deviation 1.4994
|
-2.158 ug/mL
Standard Deviation 1.5545
|
|
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Change from Baseline to Visit 23/Day 85
|
-0.585 ug/mL
Standard Deviation 1.2964
|
-1.299 ug/mL
Standard Deviation 1.4768
|
|
Changes From Baseline in Sex Hormone-Binding Globulin Levels
Change from Baseline to Visit 18/Day 78
|
-1.091 ug/mL
Standard Deviation 1.3419
|
-2.203 ug/mL
Standard Deviation 1.5719
|
SECONDARY outcome
Timeframe: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: Subjects that had follicles measured and counted were analyzed
Number of follicles greater than or equal to 6mm at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 1/Day 1
|
2.5 Number of Follicles
Standard Deviation 2.16
|
2.1 Number of Follicles
Standard Deviation 1.77
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 3/Day 5
|
3.4 Number of Follicles
Standard Deviation 2.71
|
3.8 Number of Follicles
Standard Deviation 4.64
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 4/Day 8
|
3.2 Number of Follicles
Standard Deviation 3.05
|
3.1 Number of Follicles
Standard Deviation 3.03
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 5/Day 11
|
2.7 Number of Follicles
Standard Deviation 1.91
|
2.4 Number of Follicles
Standard Deviation 1.92
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 7/Day 18
|
1.9 Number of Follicles
Standard Deviation 1.65
|
2.1 Number of Follicles
Standard Deviation 2.05
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 8/Day 22
|
1.2 Number of Follicles
Standard Deviation 1.31
|
2.4 Number of Follicles
Standard Deviation 4.94
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 9/Day 25
|
1.6 Number of Follicles
Standard Deviation 1.83
|
2.0 Number of Follicles
Standard Deviation 2.03
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 10/Day 29
|
2.6 Number of Follicles
Standard Deviation 2.47
|
2.0 Number of Follicles
Standard Deviation 1.58
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 12/Day 36
|
2.7 Number of Follicles
Standard Deviation 2.84
|
2.6 Number of Follicles
Standard Deviation 2.35
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 13/Day 43
|
2.4 Number of Follicles
Standard Deviation 2.23
|
2.1 Number of Follicles
Standard Deviation 1.99
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 14/Day 50
|
1.6 Number of Follicles
Standard Deviation 1.76
|
2.2 Number of Follicles
Standard Deviation 1.71
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 15/Day 57
|
2.3 Number of Follicles
Standard Deviation 2.14
|
2.9 Number of Follicles
Standard Deviation 3.30
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 16/Day 64
|
2.6 Number of Follicles
Standard Deviation 2.50
|
2.8 Number of Follicles
Standard Deviation 2.84
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 17/Day 71
|
2.4 Number of Follicles
Standard Deviation 2.13
|
2.3 Number of Follicles
Standard Deviation 2.35
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Visit 18/Day 78
|
2.1 Number of Follicles
Standard Deviation 1.97
|
1.9 Number of Follicles
Standard Deviation 1.96
|
|
Ovarian Follicular Activity Measured by the Number of Follicles Greater Than or Equal to 6mm
Baseline
|
2.9 Number of Follicles
Standard Deviation 2.59
|
2.9 Number of Follicles
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: Subjects that had follicles measured and counted were analyzed
Maximum diameter of largest ovarian follicle measured at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 4/Day 8
|
16.0 mm
Standard Deviation 5.34
|
16.0 mm
Standard Deviation 7.35
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 5/Day 11
|
16.1 mm
Standard Deviation 7.13
|
17.4 mm
Standard Deviation 7.85
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 7/Day 18
|
15.1 mm
Standard Deviation 9.71
|
18.8 mm
Standard Deviation 11.76
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 8/Day 22
|
16.6 mm
Standard Deviation 11.64
|
17.3 mm
Standard Deviation 10.96
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 9/Day 25
|
15.0 mm
Standard Deviation 9.80
|
18.8 mm
Standard Deviation 12.82
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 10/Day 29
|
12.9 mm
Standard Deviation 8.51
|
17.0 mm
Standard Deviation 11.94
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 12/Day 36
|
16.0 mm
Standard Deviation 7.55
|
18.1 mm
Standard Deviation 11.34
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 13/Day 43
|
16.2 mm
Standard Deviation 9.35
|
18.5 mm
Standard Deviation 9.83
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 14/Day 50
|
16.1 mm
Standard Deviation 10.49
|
16.7 mm
Standard Deviation 8.23
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 15/Day 57
|
16.9 mm
Standard Deviation 11.06
|
14.5 mm
Standard Deviation 7.41
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 16/Day 64
|
18.3 mm
Standard Deviation 10.36
|
13.5 mm
Standard Deviation 6.80
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 17/Day 71
|
17.9 mm
Standard Deviation 11.60
|
16.5 mm
Standard Deviation 8.13
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 18/Day 78
|
16.7 mm
Standard Deviation 11.32
|
16.8 mm
Standard Deviation 9.58
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Baseline
|
15.9 mm
Standard Deviation 6.00
|
16.1 mm
Standard Deviation 6.09
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 1/Day 1
|
9.9 mm
Standard Deviation 3.60
|
10.4 mm
Standard Deviation 5.27
|
|
Ovarian Follicular Activity Measured by the Maximum Diameter of the Largest Ovarian Follicle
Visit 3/Day 5
|
13.0 mm
Standard Deviation 4.08
|
12.9 mm
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: Days 0, 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: Subjects that had follicles measured and counted were analyzed
Average diameter of largest ovarian follicle measured at Baseline, Visits 1-10, Visits 12-18 (Days 1, 5, 8, 11, 18, 22, 25, 29, 36, 43, 50, 57, 64, 71, 78)
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Baseline
|
14.2 mm
Standard Deviation 5.7
|
14.5 mm
Standard Deviation 5.30
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 1/Day 1
|
8.7 mm
Standard Deviation 3.34
|
9.0 mm
Standard Deviation 4.90
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 3/Day 5
|
11.8 mm
Standard Deviation 3.85
|
11.6 mm
Standard Deviation 5.98
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 4/Day 8
|
14.4 mm
Standard Deviation 5.00
|
14.5 mm
Standard Deviation 6.54
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 5/Day 11
|
14.4 mm
Standard Deviation 6.21
|
15.4 mm
Standard Deviation 7.29
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 7/Day 18
|
13.7 mm
Standard Deviation 9.08
|
16.9 mm
Standard Deviation 10.68
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 8/Day 22
|
14.4 mm
Standard Deviation 9.82
|
15.6 mm
Standard Deviation 10.14
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 9/Day 25
|
12.8 mm
Standard Deviation 8.29
|
16.8 mm
Standard Deviation 11.92
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 10/Day 29
|
11.5 mm
Standard Deviation 7.57
|
15.4 mm
Standard Deviation 10.69
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 12/Day 36
|
14.4 mm
Standard Deviation 6.88
|
16.2 mm
Standard Deviation 9.99
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 13/Day 43
|
14.3 mm
Standard Deviation 8.83
|
16.8 mm
Standard Deviation 9.04
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 14/Day 50
|
14.5 mm
Standard Deviation 9.45
|
14.8 mm
Standard Deviation 7.56
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 15/Day 57
|
14.8 mm
Standard Deviation 9.87
|
13.1 mm
Standard Deviation 6.89
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 16/Day 64
|
16.6 mm
Standard Deviation 9.70
|
11.8 mm
Standard Deviation 5.88
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 17/Day 71
|
15.7 mm
Standard Deviation 10.55
|
14.9 mm
Standard Deviation 7.45
|
|
Ovarian Follicular Activity Measured by the Average Diameter of the Largest Ovarian Follicle
Visit 18/Day 78
|
14.7 mm
Standard Deviation 10.24
|
15.1 mm
Standard Deviation 8.73
|
SECONDARY outcome
Timeframe: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeksPopulation: Subjects that had serum progesterone measured during the respective weeks
Number of subjects that possibly ovulated based on serum progesterone \> 3.0 ng/mL but \<10 ng/mL measured during Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Weeks 1-4
|
14 Participants
|
15 Participants
|
|
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Weeks 5-8
|
27 Participants
|
8 Participants
|
|
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Weeks 9-11
|
16 Participants
|
7 Participants
|
|
Number of Subjects That Possibly Ovulated (Serum Progesterone 3-10 ng/mL)
Post-Treatment Week 12
|
18 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12, up to 12 weeksPopulation: Subjects that had serum progesterone measured during the respective weeks
Number of subjects that possibly ovulated based on serum progesterone \> 10 ng/mL measured during Weeks 1-4, 5-8, 9-11, and Post-Treatment Week 12
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=57 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Weeks 9-11
|
12 Participants
|
6 Participants
|
|
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Post-Treatment Week 12
|
7 Participants
|
5 Participants
|
|
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Weeks 1-4
|
29 Participants
|
9 Participants
|
|
Number of Subjects That Likely Ovulated (Serum Progesterone > 10 ng/mL)
Weeks 5-8
|
12 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12, up to 12 WeeksPopulation: subjects that completed diaries during the specified timeframe
Bleeding and spotting days are recorded via subject diary and the number of days of bleeding and spotting are assessed during Weeks 1-4, Weeks 5-8, Weeks 5-9, and Post-Treatment Week 12
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Weeks 1-4
|
7.5 Number of Days
Standard Deviation 3.47
|
7.4 Number of Days
Standard Deviation 3.73
|
|
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Weeks 5-8
|
6.6 Number of Days
Standard Deviation 4.53
|
9.4 Number of Days
Standard Deviation 5.68
|
|
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Weeks 9-11
|
5.1 Number of Days
Standard Deviation 4.09
|
6.3 Number of Days
Standard Deviation 4.71
|
|
Bleeding Patterns Based on Number of Bleeding/Spotting Days
Post-Treatment Week 12
|
2.9 Number of Days
Standard Deviation 4.27
|
2.1 Number of Days
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, up to 78 daysPopulation: subjects that had patch site skin irritation assessed during the respective timepoints are included
Patch wearability measured by patch site skin irritation at Visit 4, Visit 6, Visit 8, Visit 10, Visits 12-18 (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78) based on the following criteria: None= No irritation or barely perceptible/spotty erythema; Mild= Mild erythema covering approximately \<50% of the application site; Moderate = Moderate erythema covering approximately \>=50% of the application site, possible presence of mild edema; Significant = Severe erythema, possible edema, vesiculation, bullae and/or ulceration.
Outcome measures
| Measure |
Dose Level AG1000-6.5
n=61 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 Participants
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Patch Wearability Based on Skin Irritation
Visit 4/Day 8: None
|
55 Participants
|
47 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 4/Day 8: Mild
|
5 Participants
|
9 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 4/Day 8: Moderate
|
0 Participants
|
2 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 4/Day 8: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 6/Day 15: None
|
50 Participants
|
42 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 6/Day 15: Mild
|
7 Participants
|
13 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 6/Day 15: Moderate
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 6/Day 15: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 8/Day 22: None
|
53 Participants
|
45 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 8/Day 22: Mild
|
6 Participants
|
7 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 8/Day 22: Moderate
|
0 Participants
|
3 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 8/Day 22: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 10/Day 29: None
|
52 Participants
|
42 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 10/Day 29: Mild
|
5 Participants
|
9 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 10/Day 29: Moderate
|
1 Participants
|
3 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 10/Day 29: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 12/Day 36: None
|
53 Participants
|
38 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 12/Day 36: Mild
|
5 Participants
|
15 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 12/Day 36: Moderate
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 12/Day 36: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 13/Day 43: None
|
48 Participants
|
37 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 13/Day 43: Mild
|
8 Participants
|
14 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 13/Day 43: Moderate
|
1 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 13/Day 43: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 14/Day 50: None
|
53 Participants
|
39 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 14/Day 50: Mild
|
2 Participants
|
10 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 15/Day 57: Mild
|
6 Participants
|
10 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 15/Day 57: Moderate
|
1 Participants
|
3 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 15/Day 57: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 16/Day 64: None
|
45 Participants
|
39 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 16/Day 64: Mild
|
11 Participants
|
8 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 16/Day 64: Moderate
|
0 Participants
|
2 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 16/Day 64: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 17/Day 71: None
|
51 Participants
|
39 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 17/Day 71: Mild
|
4 Participants
|
6 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 17/Day 71: Moderate
|
2 Participants
|
3 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 17/Day 71: Significant
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 18/Day 78: None
|
53 Participants
|
40 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 18/Day 78: Mild
|
3 Participants
|
6 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 18/Day 78: Moderate
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 18/Day 78: Significant
|
0 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 14/Day 50: Moderate
|
2 Participants
|
1 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 14/Day 50: Significant
|
0 Participants
|
0 Participants
|
|
Patch Wearability Based on Skin Irritation
Visit 15/Day 57: None
|
50 Participants
|
36 Participants
|
Adverse Events
Dose Level AG1000-6.5
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Dose Level AG1000-12.5
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level AG1000-6.5
n=61 participants at risk
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 participants at risk
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/61
|
1.7%
1/60 • Number of events 1
|
Other adverse events
| Measure |
Dose Level AG1000-6.5
n=61 participants at risk
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 6.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 6.5mg patch daily for 11 weeks
|
Dose Level AG1000-12.5
n=60 participants at risk
levonorgestrel patch with BMI 32 kg/m2 to \<40 kg/m2: 12.5mg patch daily for 11 weeks
levonorgestrel patch with BMI \<32 kg/m2: 12.5mg patch daily for 11 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.6%
4/61
|
0.00%
0/60
|
|
Gastrointestinal disorders
Nausea
|
8.2%
5/61
|
8.3%
5/60
|
|
General disorders
Application site discolouration
|
1.6%
1/61
|
5.0%
3/60
|
|
General disorders
Application site irritation
|
19.7%
12/61
|
35.0%
21/60
|
|
General disorders
Fatigue
|
1.6%
1/61
|
5.0%
3/60
|
|
General disorders
Pain
|
0.00%
0/61
|
5.0%
3/60
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
4/61
|
10.0%
6/60
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
7/61
|
13.3%
8/60
|
|
Infections and infestations
Urinary tract infection
|
4.9%
3/61
|
6.7%
4/60
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
4/61
|
3.3%
2/60
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
4/61
|
3.3%
2/60
|
|
Nervous system disorders
Headache
|
31.1%
19/61
|
40.0%
24/60
|
|
Reproductive system and breast disorders
Breast tenderness
|
9.8%
6/61
|
5.0%
3/60
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.6%
4/61
|
6.7%
4/60
|
|
Reproductive system and breast disorders
Menstruation irregular
|
8.2%
5/61
|
11.7%
7/60
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
11.5%
7/61
|
16.7%
10/60
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.2%
5/61
|
1.7%
1/60
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
26.2%
16/61
|
33.3%
20/60
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.2%
5/61
|
1.7%
1/60
|
|
Vascular disorders
Hot flush
|
0.00%
0/61
|
5.0%
3/60
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60