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Nomegestrol

Phase 2

Contraception | Small molecule | Other |Organon & Co.|Last Updated: May 28, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment666
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01709318A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)PHASE2 COMPLETED 666Dec 12, 2012Oct 22, 2013May 28, 2024 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With Ovulation Incidence, by Cycle
Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)

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).

Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle
Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)

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.

Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3
Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 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.

Secondary Endpoints
Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2
Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Withdrawal Bleeding During Cycle 2
Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3
Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/dayEXPERIMENTALParticipants will receive 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/dayEXPERIMENTALParticipants will receive 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/dayEXPERIMENTALParticipants will receive 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/dayEXPERIMENTALParticipants will receive 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/dayEXPERIMENTALParticipants will receive 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/dayEXPERIMENTALParticipants will receive 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®ACTIVE_COMPARATORParticipants will receive 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.
Interventions
NameTypeDescription
Nomegestrol acetate (NOMAC)DRUGDaily release of 500, 700, or 900 μg.
Etonogestrel (ENG)DRUGDaily release of 75, 100, 120 or 125 μg
Ethinyl estradiol (EE)DRUGDaily release of 15 μg
Estradiol (E2)DRUGDaily release of 300 μg
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Eligibility Criteria
Age Range18 Years — 35 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Body mass index (BMI) ≥18 and ≤35 * Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3 days permitted within this range * Good physical and mental health Exclusion Criteria: * Diabetes mellitus with vascular involvement * Presence of a seve...

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