Trial Outcomes & Findings for Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062) (NCT NCT02616146)
NCT ID: NCT02616146
Last Updated: 2024-05-17
Results Overview
The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
TERMINATED
PHASE3
2016 participants
Up to 1 year (13 28-day cycles)
2024-05-17
Participant Flow
Note: One participant less than 18 years of age was inadvertently randomized and received study medication. She was discontinued from the study due to the major protocol violation.
Participant milestones
| Measure |
ENG-E2 125 μg/300 μg
Participants were to receive up to 13 cycles of etonogestrel + 17β-estradiol (ENG-E2) 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
Participants were to receive up to 13 cycles of levonorgestrel-ethinyl estradiol (LNG-EE) 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Overall Study
STARTED
|
1512
|
504
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1512
|
504
|
Reasons for withdrawal
| Measure |
ENG-E2 125 μg/300 μg
Participants were to receive up to 13 cycles of etonogestrel + 17β-estradiol (ENG-E2) 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
Participants were to receive up to 13 cycles of levonorgestrel-ethinyl estradiol (LNG-EE) 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Overall Study
Adverse Event
|
64
|
24
|
|
Overall Study
Lost to Follow-up
|
23
|
13
|
|
Overall Study
Non-compliance with study protocol
|
2
|
0
|
|
Overall Study
Non-compliance with study drug
|
4
|
2
|
|
Overall Study
Pregnancy
|
2
|
2
|
|
Overall Study
Pregnancy wish
|
3
|
0
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Study terminated by sponsor
|
1372
|
432
|
|
Overall Study
Participant moved
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
30
|
24
|
|
Overall Study
Physician Decision
|
2
|
1
|
Baseline Characteristics
Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)
Baseline characteristics by cohort
| Measure |
ENG-E2 125 μg/300 μg
n=1512 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=504 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
Total
n=2016 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 Years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
27.5 Years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
27.5 Years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1512 Participants
n=5 Participants
|
504 Participants
n=7 Participants
|
2016 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year (13 28-day cycles)Population: restricted Full Analysis Set (rFAS) population, defined as the population of women with at least one "at risk" treatment cycle without documented use of hormonal or nonhormonal backup contraception during the cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy has occurred.
The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
Outcome measures
| Measure |
ENG-E2 125 μg/300 μg
n=1266 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=404 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)
|
1.54 Pregnancies per 100 woman years
|
2.93 Pregnancies per 100 woman years
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
Outcome measures
| Measure |
ENG-E2 125 μg/300 μg
n=1504 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
530 Participants
|
140 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
Outcome measures
| Measure |
ENG-E2 125 μg/300 μg
n=1504 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Number of Participants Who Discontinued Treatment Due to an AE
|
61 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive.
BTB-S was considered any bleeding/spotting that occurred during expected non-bleeding interval that was neither early nor continued withdrawal bleeding. BTB-S was classified as follows: 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. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
Outcome measures
| Measure |
ENG-E2 125 μg/300 μg
n=1504 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 2
|
166 Participants
|
54 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 3
|
112 Participants
|
36 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 4
|
79 Participants
|
20 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 5
|
42 Participants
|
13 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 6
|
29 Participants
|
8 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 7
|
13 Participants
|
7 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 8
|
8 Participants
|
2 Participants
|
|
Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle
Cycle 9
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive.
Participants were asked to keep a daily diary to record vaginal bleeding events. AWB was defined as no bleeding/spotting during the expected bleeding period. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
Outcome measures
| Measure |
ENG-E2 125 μg/300 μg
n=1504 Participants
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 Participants
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 1
|
76 Participants
|
15 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 2
|
34 Participants
|
10 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 3
|
26 Participants
|
10 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 4
|
17 Participants
|
6 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 5
|
3 Participants
|
0 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 6
|
3 Participants
|
1 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 7
|
0 Participants
|
2 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 8
|
0 Participants
|
1 Participants
|
|
Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle
Cycle 9
|
0 Participants
|
0 Participants
|
Adverse Events
ENG-E2 125 μg/300 μg
LNG-EE 150 μg/30 μg
Serious adverse events
| Measure |
ENG-E2 125 μg/300 μg
n=1504 participants at risk
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 participants at risk
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Foreign body
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Nervous system disorders
Epilepsy
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/1504 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.20%
1/492 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Infections and infestations
Dengue fever
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/1504 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.20%
1/492 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Nervous system disorders
Syncope
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Product Issues
Device deployment issue
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.07%
1/1504 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.00%
0/492 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1504 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.20%
1/492 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1504 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
0.20%
1/492 • Number of events 1 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
Other adverse events
| Measure |
ENG-E2 125 μg/300 μg
n=1504 participants at risk
Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
|
LNG-EE 150 μg/30 μg
n=492 participants at risk
Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval.
|
|---|---|---|
|
Nervous system disorders
Headache
|
7.7%
116/1504 • Number of events 180 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
8.1%
40/492 • Number of events 68 • Up to 1 year
Safety analysis was based on all randomized participants in whom at least 1 vaginal ring was inserted or one comparator tablet was ingested. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
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.
- Publication restrictions are in place
Restriction type: OTHER