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DR-2011

Phase 3

Infertility | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: May 12, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment1,317

FDA Designations

No designations recorded

Clinical trial landscape

DR-2011 · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00615251A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro FertilizationInfertility
COMPLETED1,297 Analytics
PHASE3COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization
InfertilityUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
Adequate endometrial transformation
Cycle Day 25 or 26

Secondary Endpoints

Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy
Duration of study
Adverse events
Duration of study
Hormone levels
Duration of study
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
DR-2011DRUGProgesterone vaginal ring for approximately 10 weeks
Crinone 8%DRUGprogesterone vaginal gel for approximately 10 weeks
Progesterone 8% Vaginal GelDRUGAdministered vaginally from Cycle Day 14 to Day 31
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Eligibility Criteria

Age Range18 Years to 42 Years
SexFEMALE
Healthy VolunteersYes
Study Sites29

Inclusion Criteria: * Pre-menopausal, aged 18-42 old at time of consent * At least one cycle without fertility medication prior to screening * Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility * Semen analysis (frozen sperm, including donor sperm, may be use...

Countries:United States
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Frequently asked questions about DR-2011

What is DR-2011 used for?

DR-2011 is an investigational small molecule being developed for infertility. It is being studied for luteal phase replacement and for use in in vitro fertilization. The drug is currently in Phase 3 clinical development and is not approved by the FDA.

Who makes DR-2011?

DR-2011 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting clinical trials to evaluate the drug's efficacy and safety for infertility treatment.

What phase is DR-2011 in?

DR-2011 is in Phase 3 clinical development. It has completed two clinical trials, including a Phase 3 study with 1,297 participants. The drug is investigational and has not received FDA approval.

What clinical trials is DR-2011 in?

DR-2011 has completed two clinical trials. NCT00117468 was a Phase 2 study comparing DR-2011 to a progesterone vaginal gel for luteal phase replacement, enrolling 20 participants. NCT00615251 was a Phase 3 trial evaluating DR-2011 for in vitro fertilization, enrolling 1,297 participants.

How does DR-2011 work?

DR-2011 is a small molecule being studied for infertility. The specific molecular target of DR-2011 has not been disclosed in the available clinical trial information.