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This study was terminated by the Sponsor due to a business decision to discontinue product development for reasons unrelated to safety or efficacy outcomes.
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The purpose of this study is to assess the contraceptive efficacy of the Etonogestrel (ENG) + 17β-Estradiol (E2) vaginal ring in women between 18 and 35 years of age based on the number of in-treatment pregnancies as expressed by the Pearl Index (PI). The study will also assess the safety and tolerability of the ENG-E2 vaginal ring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENG-E2 125 μg/300 μg | Experimental | Participants will receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle will consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENG-E2 125 μg/300 μg vaginal ring | Drug | Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | The Pearl Index is the number of in-treatment pregnancies with a conception date in any of the in-treatment cycles, divided by all treatment cycles in each participant from the first treatment cycle to the last treatment cycle (due either to discontinuation or completion), regardless of whether a treatment cycle was "at risk" or not. One woman-year is defined as 13 treatment cycles x 28 days. These efficacy results should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of "at risk" treatment cycles in the denominator is based on uncleaned diary data. | Up to 1 year (13 28-day cycles) |
| Number of Participants With One or More Adverse Events (AEs) | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
| Number of Participants Who Discontinued Treatment Due to an AE | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | ENG-E2 125 μg/300 μg | Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ENG-E2 125 μg/300 μg | Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index) | The Pearl Index is the number of in-treatment pregnancies with a conception date in any of the in-treatment cycles, divided by all treatment cycles in each participant from the first treatment cycle to the last treatment cycle (due either to discontinuation or completion), regardless of whether a treatment cycle was "at risk" or not. One woman-year is defined as 13 treatment cycles x 28 days. These efficacy results should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of "at risk" treatment cycles in the denominator is based on uncleaned diary data. | All participants assigned to treatment who inserted at least 1 ENG-E2 ring, and who had at least 1 "at risk" treatment cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy had occurred (i.e., treatment cycle containing an estimated conception date for a pregnancy). | Posted | Number | Pregnancies per 100 woman years | Up to 1 year (13 28-day cycles) |
|
From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)
All randomized participants in whom at least 1 vaginal ring was inserted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENG-E2 125 μg/300 μg | Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitello-intestinal duct remnant | Congenital, familial and genetic disorders | MedDRA Version 17.1 | Systematic Assessment |
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Results for the Pearl Index should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of "at risk" treatment cycles in the denominator is based on uncleaned diary data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
| Number of Participants With One or More Drug-related AEs | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related. | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
| Number of Participants Who Discontinued Treatment Due to a Drug-related AE | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related. | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
| Non-Compliance With Study Drug |
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| Pregnancy Wish |
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| Protocol Violation |
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| Screen Failure |
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| Site Discontinued Study Participation |
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| Study Terminated By Sponsor |
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| Subject Moved |
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| Withdrawal by Subject |
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| Pregnancy |
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| Physician Decision |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | ENG-E2 125 μg/300 μg | Participants were to receive up to 13 cycles of Etonogestrel (ENG) 125 μg and 17β-Estradiol (E2) 300 μg. Each cycle would consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. |
|
|
| Primary | Number of Participants With One or More Adverse Events (AEs) | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All randomized participants in whom at least 1 vaginal ring was inserted. | Posted | Number | Participants | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
|
|
|
| Primary | Number of Participants Who Discontinued Treatment Due to an AE | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. | All randomized participants in whom at least 1 vaginal ring was inserted. | Posted | Number | Participants | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
|
|
|
| Primary | Number of Participants With One or More Drug-related AEs | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related. | All randomized participants in whom at least 1 vaginal ring was inserted. | Posted | Number | Participants | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
|
|
|
| Primary | Number of Participants Who Discontinued Treatment Due to a Drug-related AE | 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 pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related. | All randomized participants in whom at least 1 vaginal ring was inserted. | Posted | Number | Participants | From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year) |
|
|
|
| 12 |
| 1,936 |
| 0 |
| 1,936 |
| Goitre | Endocrine disorders | MedDRA Version 17.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 17.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA Version 17.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 17.1 | Systematic Assessment |
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| Ruptured ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 17.1 | Systematic Assessment |
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| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA Version 17.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 17.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.1 | Systematic Assessment |
|
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.