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CompletedNCT04173169PREGnantUpdated Jun 12, 2026Results posted

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis

A Phase 3 interventional study of Elagolix 200 MG and Placebo or SOC IVF in Infertility and Endometriosis, sponsored by Yale University. Completed at 5 sites in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Yale University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

A Phase 3 clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist.

Read the detailed description

Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis-associated infertility, pregnancy rates are diminished compared to other etiologies of infertility. The study's long- term objectives are to better identify and treat endometriosis related infertility. The investigators' central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization-embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to those not pretreated with GnRH antagonist. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Further, use of this approach is limited by the long treatment time required. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. This agent avoids parenteral administration and the prolonged delay in initiation of action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. The investigators propose a clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. Participants will include those who agree to be randomized and those who do not want to be randomized. Those who agree to be randomized will be randomly assigned to either the elagolix group or placebo group. Those who do not want to be randomized can choose either the active treatment elagolix and follow the same procedures as those agreeing to be randomized or continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.

02

Conditions studied

  • Infertility
  • Endometriosis
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 103 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Women who plan to undergo IVF for treatment of infertility.
  2. Age ≥18 and \<40 years at time of egg retrieval or signing informed consent.
  3. Documentation of diagnosis of endometriosis by surgical visualization of endometriosis (laparoscopy or laparotomy) or diagnosis by pathology within the last 10 years before the initial trial entry visit or documentation of ovarian endometrioma >2 cm or two or more smaller endometriomas that total >2 cm in diameter. If entry is based on the presence of an endometrioma, transvaginal ultrasound evaluation must document the same unambiguous endometrioma on two separate occasions in more than one menstrual cycle. Images will be printed or transmitted electronically and read centrally by investigators at Yale to assure uniform diagnostic criteria (classic ground glass appearance) are applied.
  4. Body mass index (BMI) of 18-40 kg/m2 (both inclusive) at screening.
  5. AMH > 0.5ng/ml, within 12 months of a fresh IVF cycle start. For frozen embryo transfers (FET) , AMH level eligibility criteria may not be met as long as the patient has at least one good quality blastocyst stored for the FET.
  6. No known uterine cavity abnormalities at time of screening. Uterine cavity assessment by sonohysterogram or hysteroscopy within 12 months of embryo transfer indicating absence of focal intracavitary pathology and hence establishing adequate cavity at the time of embryo transfer. Ultrasound or MRI features suggestive of adenomyosis will be acceptable for inclusion. Type 3 fibroids are allowed up to 4cm size.
  7. Presence of at least one ovary with no clinically significant abnormalities other than endometrioma. For eligible women with evidence of a hemorrhagic ovarian cyst, a repeat US will be needed in a subsequent menstrual cycle to ensure persistent cyst for patient to be deemed eligible.
  8. Negative urine or cervical swab for gonorrhea and chlamydia within 12 months of screening.
  9. Willing and able to comply with trial procedures, including reporting of obstetrical outcomes after delivery.

Exclusion criteria

Exclusion Criteria:

  1. Use of depot GnRH agonists within 6 months of study start. Use of subcutaneous antagonists or nasal agonist within 2 months of study start unless part of regular IVF or previous IUI cycle°.
  2. Use of depot medroxyprogesterone acetate (MPA) (injectable) or birth control implants (e.g., Implanon® or Nexplanon®) within 6 months of study start°.
  3. Continuous use of oral progestins (MPA, NETA) within 1 month of study start°.
  4. Use of aromatase inhibitors, danazol or hormonal contraceptives (Including combined oral contraceptive pill, progestin-only pill, transdermal patch or contraceptive ring, or double barrier contraception) within 1 month of study start.
  5. Pregnancy greater than 8 weeks in length within the last 6 months.
  6. Number of previous IVF/ICSI attempts ≥3 unsuccessful (negative pregnancy test).
  7. Presence of hydrosalpinx measuring >2cm on ultrasound, untreated endometrial polyps or intrauterine adhesions.
  8. Abnormal cytology on a cervical screening based on the American College of Obstetricians and Gynecologists (ACOG) guidelines and patient age. (CIN1 or HPV allowed to participate in the study, CIN2 excluded unless treated and cleared, CIN3 excluded).
  9. History of malignancy within 5 years of the start of screening, except for treated basal cell carcinoma and squamous cell carcinoma of the skin.
  10. Any thoughts of suicide in the last 12 months per self-report, or documented in the electronic medical record (EMR).
  11. Hypersensitivity to the study drugs.
  12. Planned surgical treatment of endometriosis or planned surgery in the abdominal-pelvic area within the duration of the trial.
  13. Untreated abnormal prolactin or TSH
  14. Any conditions that preclude pregnancy.
  15. Patients with a known history of a low-trauma fracture or other risk factors for osteoporosis or bone loss.

  16. Patients with cirrhosis or abnormal LFTs per self report or documented in the electronic medical record (EMR).

    • Exclusion criteria number 1,2, and 3 are not required to be met by individuals in the standard of care arm of the study. The study team will collect the information regarding whether the subject has used these drugs in the aforementioned time frame using the concomitant medication log and the individual will be allowed to participate in the study under the standard of care arm only.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
103 participants (actual)

Study arms

  • Active comparator
    Pre-IVF Treatment with 60 day course of oral GnRH antagonist

    For those who agree to be randomized, subjects will be randomized to elagolix 200mg BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who do not want to be randomized while choose elagolix.

    Drug: Elagolix 200 MG

  • Other
    Pre-IVF Treatment with 60 day course of Placebo or SOC IVF

    For those who agree to be randomized, subjects will be randomized to placebo, BID. The medication will be taken orally and subjects will be counseled to take the medication at the same time each day. This arm will also include participants who want to continue their ongoing or planned IVF and follow standard of care (SOC) (SOC IVF) if they do not want to delay the IVF procedure.

    Other: Placebo or SOC IVF

Interventions

  • DrugElagolix 200 MG

    Elagolix tablet

    Also known as: Orlissa

  • OtherPlacebo or SOC IVF

    Sugar pill manufactured to mimic Elagolix 200mg

06

What researchers measure

Primary outcomes

  1. Live Birth Rate

    The percentage of the number of participants with a live birth at ≥24 weeks of gestation out of those who were enrolled in the study

    Time frame: Up to 15 months

Secondary outcomes

  1. Fertilization Rate

    The percentage of the total number of fertilized oocytes (two pronuclei) out of the total number of injected/inseminated oocytes across all participants in each Arm/Group who had the current or previous IVF data

    Time frame: Up to 9 months

  2. Number of Embryos Transferred

    Number of embryos transferred per participant

    Time frame: Up to 9 months

  3. Implantation Rate

    The percentage of the total number of gestation sacs visible by Ultrasound out of the total number of transferred embryos across all participants in each Arm/Group who completed embryo transfer

    Time frame: Up to 9 months

  4. Biochemical Pregnancy Rate

    The percentage of the number of participants with positive pregnancy tests following embryo transfer out of those who were enrolled in the study

    Time frame: Up to 9 months

  5. Clinical Pregnancy Rate

    The percentage of the number of participants with ultrasound evidence of intrauterine gestational sac with fetal cardiac activity out of those who were enrolled in the study

    Time frame: Up to 10 months

  6. Miscarriage Rate

    Percentage of the number of participants with a pregnancy loss out of those who have achieved pregnancy

    Time frame: Up to 10 months

  7. Overall Pregnancy Complication Rate

    Percentage of the number of participants who had the overall pregnancy complication out of those who have achieved pregnancy. Overall pregnancy complication including any of the following: preterm delivery, preeclampsia, gestational diabetes, intrauterine growth restriction, incompetent cervix, premature rupture of membrane, incidence of abnormal placentation (placenta previa, accreta, increta, percreta, abruption), bleeding in pregnancy (antepartum or postpartum)

    Time frame: Up to 15 months

  8. Gestation Age at Delivery

    Gestation age (weeks) at delivery per infant delivered

    Time frame: Up to 15 months

  9. Infant Birth Weight

    Infant birth weight (gram) per infant delivered.

    Time frame: Up to 15 months

07

Results

Posted Jun 12, 2026
Limitations and caveats
Early termination of this part of study by NIH leading to small number of subjects enrolled and analyzed. Results from other part of the study (with different sponsorship and different NCT number) were not included.

Participant flow

Participant flow — Overall Study
MilestonePre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Started5350
Per protocol3740
Completed4047
Not completed133
Withdrew: Withdrawal by subject133

Outcome measures

PrimaryLive Birth Rate

The percentage of the number of participants with a live birth at ≥24 weeks of gestation out of those who were enrolled in the study

Time frame:
Up to 15 months
Reported as:
Count of participants · Participants
Live Birth Rate
ParticipantsPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Live Birth Rate2022
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Chi-squared · p = 0.52 · Risk ratio (rr): 0.86 · 95% CI 0.54 to 1.37
SecondaryFertilization Rate

The percentage of the total number of fertilized oocytes (two pronuclei) out of the total number of injected/inseminated oocytes across all participants in each Arm/Group who had the current or previous IVF data

Time frame:
Up to 9 months
Reported as:
Count of units · Total no. oocytes injected/inseminated
Fertilization Rate
Total no. oocytes injected/inseminatedPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Fertilization Rate194291
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Generalized Linear Model · p = 0.43 · Risk ratio (rr): 0.96 · 95% CI 0.80 to 1.13
SecondaryNumber of Embryos Transferred

Number of embryos transferred per participant

Time frame:
Up to 9 months
Reported as:
Mean · Number of embryos transferred
Number of Embryos Transferred
Number of embryos transferredPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Number of Embryos Transferred1.1 ± 0.31.0 ± 0.2
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · t-test, 2 sided · p = 0.14 · Mean difference (final values): 0.1 · 95% CI 0.03 to 0.2
SecondaryImplantation Rate

The percentage of the total number of gestation sacs visible by Ultrasound out of the total number of transferred embryos across all participants in each Arm/Group who completed embryo transfer

Time frame:
Up to 9 months
Reported as:
Count of units · Total no. of embryo transferred
Implantation Rate
Total no. of embryo transferredPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Implantation Rate2223
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Generalized Linear Model · p = 0.78 · Risk ratio (rr): 1.06 · 95% CI 0.70 to 1.59
SecondaryBiochemical Pregnancy Rate

The percentage of the number of participants with positive pregnancy tests following embryo transfer out of those who were enrolled in the study

Time frame:
Up to 9 months
Reported as:
Count of participants · Participants
Biochemical Pregnancy Rate
ParticipantsPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Biochemical Pregnancy Rate2629
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Chi-squared · p = 0.36 · Risk ratio (rr): 0.85 · 95% CI 0.59 to 1.21
SecondaryClinical Pregnancy Rate

The percentage of the number of participants with ultrasound evidence of intrauterine gestational sac with fetal cardiac activity out of those who were enrolled in the study

Time frame:
Up to 10 months
Reported as:
Count of participants · Participants
Clinical Pregnancy Rate
ParticipantsPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Clinical Pregnancy Rate2224
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Chi-squared · p = 0.51 · Risk ratio (rr): 0.86 · 95% CI 0.56 to 1.33
SecondaryMiscarriage Rate

Percentage of the number of participants with a pregnancy loss out of those who have achieved pregnancy

Time frame:
Up to 10 months
Reported as:
Count of participants · Participants
Miscarriage Rate
ParticipantsPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Miscarriage Rate58
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Fisher Exact · p = 0.54 · Risk ratio (rr): 0.70 · 95% CI 0.26 to 1.86
SecondaryOverall Pregnancy Complication Rate

Percentage of the number of participants who had the overall pregnancy complication out of those who have achieved pregnancy. Overall pregnancy complication including any of the following: preterm delivery, preeclampsia, gestational diabetes, intrauterine growth restriction, incompetent cervix, premature rupture of membrane, incidence of abnormal placentation (placenta previa, accreta, increta, percreta, abruption), bleeding in pregnancy (antepartum or postpartum)

Time frame:
Up to 15 months
Reported as:
Count of participants · Participants
Overall Pregnancy Complication Rate
ParticipantsPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Overall Pregnancy Complication Rate1212
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Chi-squared · p = 0.72 · Risk ratio (rr): 1.12 · 95% CI 0.61 to 2.03
SecondaryGestation Age at Delivery

Gestation age (weeks) at delivery per infant delivered

Time frame:
Up to 15 months
Reported as:
Median · weeks
Gestation Age at Delivery
weeksPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Gestation Age at Delivery39.0 (37.6 to 39.4)37.6 (36.9 to 39.0)
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · Wilcoxon (Mann-Whitney) · p = 0.19
SecondaryInfant Birth Weight

Infant birth weight (gram) per infant delivered.

Time frame:
Up to 15 months
Reported as:
Mean · gram
Infant Birth Weight
gramPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Infant Birth Weight3300 ± 5203237 ± 502
Statistical analysis
  • Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist vs Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF · t-test, 2 sided · p = 0.54 · Mean difference (final values): 62 · 95% CI -279 to 403

Adverse events

Collected over UP to 16.5 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Pre-IVF Treatment With 60 Day Course of Oral GnRH Antagonist0/53 (0%)0/53 (0%)30/53 (56.6%)
Pre-IVF Treatment With 60 Day Course of Placebo or SOC IVF0/50 (0%)3/50 (6%)21/50 (42%)
Most frequent serious events
Most frequent serious events
EventPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Ectopic pregnancyPregnancy, puerperium and perinatal conditions0/531/50
Congenital birth defectCongenital, familial and genetic disorders0/531/50
Pre-eclampsia with severe featurePregnancy, puerperium and perinatal conditions0/531/50
Most frequent other events
Most frequent other events
EventPre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVF
Complications during pregnancyPregnancy, puerperium and perinatal conditions12/2612/29
Complications in infants after birth deliveryPregnancy, puerperium and perinatal conditions7/207/20
Complications in mother after birth deliveryPregnancy, puerperium and perinatal conditions5/207/22
Hot flashesNervous system disorders14/531/50
HeadachesNervous system disorders7/531/50
NauseaGastrointestinal disorders3/530/50

Baseline characteristics

Age, Continuous
Age, Continuous(years)Pre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVFTotal
Median36.0 (33.0 to 38.0)34.5 (32.0 to 37.0)35.0 (32.0 to 38.0)
Sex: Female, Male
Sex: Female, Male(Participants)Pre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVFTotal
Female5350103
Male000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Pre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVFTotal
Hispanic or Latino4913
Not Hispanic or Latino493988
Unknown or Not Reported022
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Pre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVFTotal
American Indian or Alaska Native000
Asian639
Native Hawaiian or Other Pacific Islander101
Black or African American729
White384280
More than one race022
Unknown or Not Reported112
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Pre-IVF Treatment With 60 Day Course of Oral GnRH AntagonistPre-IVF Treatment With 60 Day Course of Placebo or SOC IVFTotal
Median26.3 (23.7 to 30.0)26.1 (22.7 to 28.9)26.2 (23.6 to 30.2)
08

Study locations

5 sites
  • University of Colorado Department of Obstetrics & Gynecology
    Aurora, Colorado 80045, United States
  • Yale School of Medicine Dept.of Ob/Gyn & Reproductive Sciences
    New Haven, Connecticut 06520, United States
  • Northwestern University Department of Obstetrics and Gynecology
    Chicago, Illinois 60611, United States
  • Johns Hopkins, Division of Reproductive Science and Women's Health Research
    Baltimore, Maryland 21205, United States
  • Duke Fertility
    Morrisville, North Carolina 27560, United States
09

References and documents

Publications

  • Taylor H, Li HJ, Carson S, Flores V, Pal L, Robbins J, Santoro NF, Segars JH, Seifer D, Huang H, Young S, Zhang H. Pre-IVF treatment with a GnRH antagonist in women with endometriosis (PREGNANT): study protocol for a prospective, double-blind, placebo-controlled trial. BMJ Open. 2022 Jun 17;12(6):e052043. doi: 10.1136/bmjopen-2021-052043. PubMed 35715184 ↗
  • Pretzel S, Kuhn K, Pal L, Polotsky A, Taylor HS, Zhang H, Robins J, Young SL, Santoro N. Willingness of Women with Endometriosis Planning to Undergo IVF to Participate in a Randomized Clinical Trial and the Effects of the COVID-19 Pandemic on Potential Participation. Reprod Sci. 2022 Feb;29(2):620-626. doi: 10.1007/s43032-021-00705-0. Epub 2021 Aug 6. PubMed 34363198 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 5, 2023
  • Informed consent form · Oct 31, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — We have a plan to submit data and samples collected by the trial to NICHD DASH. The informed consent will include permission to bank these samples. The processes included initial data and documentation preparation (e.g., codebooks, protocols, informed consent for data sharing), data quality control, and submission.

Supporting information: Study protocol, Sap, Icf, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04173169
Lead sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Colorado, Denver, Northwestern University, University of North Carolina
Responsible party
Sponsor
First posted
Nov 21, 2019
Start date
Mar 15, 2022
Primary completion
May 2, 2025
Completion
May 2, 2025
Results posted
Jun 12, 2026
Last update
Jun 12, 2026

Study contacts

David Weinberg, PhD
study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Hugh Taylor, MD
principal investigator · Yale University
Heping Zhang, PhD
study director · Yale University
Nanette Santoro, MD
study director · University of Colorado, Denver
Emily Jungheim, MD
study director · Northwestern University
Steven Young, MD, PhD
study director · Duke University
Abisola Tepede, PharmD
study director · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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