Trial Outcomes & Findings for A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) (NCT NCT01709318)
NCT ID: NCT01709318
Last Updated: 2024-05-28
Results Overview
Ovulation was defined as having 2 or more consecutive progesterone concentrations \>16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure \>15 mm in size).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
666 participants
Primary outcome timeframe
Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
Results posted on
2024-05-28
Participant Flow
The study enrolled healthy female participants aged 18 to 35 years, with cycles between 24 to 35 days in length.
Of the 757 participants who were screened for inclusion in the trial, 666 participants were randomized, and 660 participants were treated.
Participant milestones
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
82
|
85
|
77
|
78
|
78
|
84
|
182
|
|
Overall Study
Treated
|
79
|
85
|
78
|
77
|
77
|
86
|
178
|
|
Overall Study
COMPLETED
|
73
|
78
|
71
|
72
|
74
|
80
|
171
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
6
|
6
|
4
|
4
|
11
|
Reasons for withdrawal
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
2
|
2
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Non-compliance with Study Drug
|
0
|
2
|
1
|
1
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
|
Overall Study
Technical Problems
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
3
|
3
|
0
|
2
|
4
|
|
Overall Study
Other Protocol Specified Criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Baseline characteristics by cohort
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Total
n=660 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.7 Years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
26.7 Years
STANDARD_DEVIATION 4.91 • n=7 Participants
|
26.1 Years
STANDARD_DEVIATION 4.46 • n=5 Participants
|
25.5 Years
STANDARD_DEVIATION 4.87 • n=4 Participants
|
26.1 Years
STANDARD_DEVIATION 4.52 • n=21 Participants
|
27.1 Years
STANDARD_DEVIATION 4.61 • n=8 Participants
|
25.9 Years
STANDARD_DEVIATION 4.82 • n=8 Participants
|
26.3 Years
STANDARD_DEVIATION 4.76 • n=24 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
86 Participants
n=8 Participants
|
178 Participants
n=8 Participants
|
660 Participants
n=24 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
85 Participants
n=8 Participants
|
174 Participants
n=8 Participants
|
645 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)Population: The analysis population included all participants in whom vaginal rings were inserted and received ultrasound and hormonal assessments, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.
Ovulation was defined as having 2 or more consecutive progesterone concentrations \>16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure \>15 mm in size).
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=65 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=73 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=57 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=60 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=63 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=65 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=126 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Ovulation Incidence, by Cycle
Cycle 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Ovulation Incidence, by Cycle
Cycle 2
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Ovulation Incidence, by Cycle
Cycle 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)Population: The analysis population included all participants in whom vaginal rings were inserted and received hormonal assessment for progesterone concentration, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.
Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations \>16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=65 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=73 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=57 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=60 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=63 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=65 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=126 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Cycle 3 Max P > 16 nmol/L
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Cycle 1 Max P > 16 nmol/L
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Cycle 2 Max P > 16 nmol/L
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)Population: The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.
Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=48 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=45 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=40 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=44 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=49 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=47 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=97 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
|
14.6 Percentage of Participants
|
13.3 Percentage of Participants
|
17.5 Percentage of Participants
|
13.6 Percentage of Participants
|
16.3 Percentage of Participants
|
6.4 Percentage of Participants
|
6.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)Population: The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.
Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=55 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=53 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=45 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=51 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=54 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=52 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=111 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
|
5.5 Percentage of Participants
|
1.9 Percentage of Participants
|
4.4 Percentage of Participants
|
7.8 Percentage of Participants
|
3.7 Percentage of Participants
|
1.9 Percentage of Participants
|
1.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)Population: The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one withdrawal bleeding or spotting day, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.
Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=52 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=52 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=43 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=47 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=52 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=51 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=109 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Intensity of Withdrawal Bleeding During Cycle 2
|
0.87 Ratio
Standard Deviation 0.25
|
0.92 Ratio
Standard Deviation 0.17
|
0.86 Ratio
Standard Deviation 0.19
|
0.90 Ratio
Standard Deviation 0.18
|
0.92 Ratio
Standard Deviation 0.18
|
0.93 Ratio
Standard Deviation 0.14
|
0.95 Ratio
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)Population: The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one breakthrough bleeding and/or spotting day, excluding protocol violators in terms of ring use, daily diary entry or prohibited medications.
Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=7 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=6 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=7 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=6 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=8 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=3 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=6 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
|
0.42 Ratio
Standard Deviation 0.45
|
0.80 Ratio
Standard Deviation 0.40
|
0.68 Ratio
Standard Deviation 0.47
|
0.73 Ratio
Standard Deviation 0.16
|
0.67 Ratio
Standard Deviation 0.43
|
0.33 Ratio
Standard Deviation 0.58
|
0.67 Ratio
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Up to ~92 daysPopulation: The analysis population included all randomized participants in whom a vaginal ring was inserted.
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Adverse Event
|
43.0 Percentage of Participants
|
40.0 Percentage of Participants
|
43.6 Percentage of Participants
|
37.7 Percentage of Participants
|
39.0 Percentage of Participants
|
46.5 Percentage of Participants
|
39.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~92 daysPopulation: The analysis population included all randomized participants in whom a vaginal ring was inserted.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~92 daysPopulation: The analysis population included all randomized participants in whom a vaginal ring was inserted.
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event
|
26.6 Percentage of Participants
|
23.5 Percentage of Participants
|
26.9 Percentage of Participants
|
29.9 Percentage of Participants
|
26.0 Percentage of Participants
|
31.4 Percentage of Participants
|
20.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~92 daysPopulation: The analysis population included all randomized participants in whom a vaginal ring was inserted.
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Any Drug-Related Serious Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~92 daysPopulation: The analysis population included all randomized participants in whom a vaginal ring was inserted.
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
|
3.8 Percentage of Participants
|
4.7 Percentage of Participants
|
2.6 Percentage of Participants
|
2.6 Percentage of Participants
|
0 Percentage of Participants
|
1.2 Percentage of Participants
|
1.1 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)Population: The analysis population included all randomized participants in whom a vaginal ring was inserted.
Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.
Outcome measures
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 Participants
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 Participants
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 Participants
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
0.0 Participants
|
Adverse Events
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
NuvaRing®
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day
n=79 participants at risk
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 500/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day
n=85 participants at risk
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 700/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day
n=78 participants at risk
Participants received nomegestrol acetate-17β-estradiol (NOMAC-E2) 900/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day
n=77 participants at risk
Participants received etonogestrel-17β-estradiol (ENG-E2) 75/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day
n=77 participants at risk
Participants received etonogestrel-17β-estradiol (ENG-E2) 100/300 μg for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day
n=86 participants at risk
Participants received etonogestrel-17β-estradiol (ENG-E2) 125/300 μg for three 28-day treatment periods, each treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
NuvaRing®
n=178 participants at risk
Participants received NuvaRing® (etonogestrel-ethinyl estradiol \[ENG-EE\] 120/15 μg) for three treatment periods, each 28-day treatment period (cycle) consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
2/79 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/85 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/78 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
7.8%
6/77 • Number of events 9 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/77 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.5%
3/86 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.1%
2/178 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Gastrointestinal disorders
Nausea
|
5.1%
4/79 • Number of events 7 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.2%
1/85 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.6%
2/78 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.2%
4/77 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/77 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.2%
1/86 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.9%
7/178 • Number of events 8 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
9/79 • Number of events 12 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.9%
5/85 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
14.1%
11/78 • Number of events 13 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
14.3%
11/77 • Number of events 14 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
9.1%
7/77 • Number of events 7 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
9.3%
8/86 • Number of events 9 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
9.0%
16/178 • Number of events 18 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
4/79 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/85 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/78 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/77 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.6%
2/77 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.3%
2/86 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.2%
4/178 • Number of events 8 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/79 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/85 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.1%
4/78 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/77 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/77 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/86 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
0.00%
0/178 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Nervous system disorders
Headache
|
15.2%
12/79 • Number of events 24 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
12.9%
11/85 • Number of events 21 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
17.9%
14/78 • Number of events 43 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
16.9%
13/77 • Number of events 35 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
19.5%
15/77 • Number of events 29 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
15.1%
13/86 • Number of events 35 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
13.5%
24/178 • Number of events 47 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.1%
4/79 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.4%
2/85 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
6.4%
5/78 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.6%
2/77 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.9%
3/77 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
7.0%
6/86 • Number of events 8 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.9%
7/178 • Number of events 11 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.3%
1/79 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
7.1%
6/85 • Number of events 9 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.1%
4/78 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.2%
4/77 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
6.5%
5/77 • Number of events 9 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
4.7%
4/86 • Number of events 6 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.7%
3/178 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
4/79 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.2%
1/85 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.6%
2/78 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
5.2%
4/77 • Number of events 5 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
1.3%
1/77 • Number of events 1 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.3%
2/86 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.2%
4/178 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.5%
2/79 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.5%
3/85 • Number of events 4 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
7.7%
6/78 • Number of events 8 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.9%
3/77 • Number of events 3 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
2.6%
2/77 • Number of events 2 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
7.0%
6/86 • Number of events 10 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
3.4%
6/178 • Number of events 6 • Up to ~92 days
The analysis population consisted of all randomized participants in whom a vaginal ring was inserted.
|
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 The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER