CompletedNCT03432416Updated Oct 31, 2025

Study of Efficacy, Cycle Control, and Safety of a NES-E2 Contraceptive Vaginal Ring

A Phase 2 interventional study of NES-E2 CVR in Healthy Women and Female Contraception, sponsored by Premier Research. Completed at 11 sites in United States. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-31.

Sponsored by Premier Research · Phase 2, Interventional, and Other

From the registry’s dates

Primary completion was Aug 2021, 5 years 2 months ago, and no results have been posted to the registry.

Phase: Phase 2
Study type: Interventional
Enrollment: 385
Allocation: Randomized
Ages: 18 Years to 35 Years
Sex: Female

Study summary

This will be a multi-site, open-label, randomized clinical trial. The investigators will randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that are to be followed when using a contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR).

Read the detailed description

The total duration of the study for each participant is expected to be approximately 13.5-15.5 months: including screening and enrollment (up to 8 weeks), 12 months of participation, and a post-removal follow up period removal of at least 17 days. After enrollment, subject visits occur at day 31, 92, 183, 274, and 364 with telephone calls at day 60, 120, 150, 210, 240, 300, and 330. Subjects will use a home pregnancy test 17 days post-removal of the ring and will call the site report the result and for safety follow-up. Another phone call will be required after that if the subject chooses not to being a hormonal contraceptive; this call will occur at the time of the subject's first spontaneous menses.

Subject recruitment is expected to begin Q1 (in the first quarter of) 2018 and is planned to continue through Q1 2019. However, if the enrollment rate declines, the enrollment period may be extended beyond this date. If this enrollment timeline is met, all subjects should finish active treatment by approximately the end of Q1 2020. The end of the study will occur when the last subject to be enrolled has completed her post-removal telephone call(s).

Preliminary results of the study are expected to be available Q3 of 2020 based on the current study plan.

Conditions studied

Healthy Women
Female Contraception

Keywords

Healthy Women
Female Contraception
Vaginal Ring
Contraceptive Vaginal Ring

In context

Lead sponsor

Premier Research is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

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

Who can participate

Ages eligible: 18 Years to 35 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.
Age 18-35 years, inclusive, at the enrollment visit. (Note: subjects must be at least 18 years of age to provide consent.)
Have a regular menstrual cycle 21-35 days in duration when not using hormonal
Have an intact uterus and at least one ovary.
Consistent use of effective contraception during the preceding cycle with no unprotected intercourse since last use (NOTE: women who use oral, transdermal, vaginal, or implantable hormonal contraceptives in the preceding cycle must have discontinued hormone use at least 4 days prior to start of treatment and must not have had unprotected intercourse since discontinuing the method. Copper IUD or Levonorgestrel releasing IUD users must have discontinued IUD use at least 4 days prior to start of treatment and have experienced a spontaneous menses following IUD removal.)
No use of injectable contraceptives (e.g. depomedroxyprogesterone acetate) during the 10 months prior to screening unless the subject has returned to normal menses (two consecutive menses) since last injection.
Have a negative pregnancy test at the enrollment visit.
Have a diastolic blood pressure (BP) \<90 mm Hg and systolic BP \<140 mm Hg after 5 minutes rest in sitting position at the admission visit (below hypertension stage 2). (Note: History of hypertension stage 2 or higher, even if controlled with treatment, is exclusionary.)
Willing to abstain from use of non-water based (including silicone based) vaginal lubricants during the study that could adversely affect the ring, causing it to expand.
Understand and sign an IRB-approved form prior to screening activities (including fasting blood draws).
≤ 35 kg/m2 and not having previously undergone bariatric surgery.
Planning to have at least one act of heterosexual intercourse without the use of another contraceptive method each month during study participation until end of treatment and at risk for pregnancy.

Exclusion criteria

Exclusion Criteria:

Planning pregnancy during study participation through the end of treatment visit.
Within 30 days post-partum, currently breast-feeding, or has not had a spontaneous menses.
Post-abortal and has not had a spontaneous menses.
Abnormal genital bleeding.
Participating in another clinical trial involving an product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
Not living in the catchment area of the study site.
Known to progestins or estrogens.
to combined estrogen-progestin use including:
1. Thrombophlebitis or thromboembolic disorders.
2. Personal history of deep vein thrombophlebitis or thromboembolic disorders.
3. History of venous thrombosis or embolism in a first-degree relative \<55 years of age suggesting a familial defect in the blood coagulation system.
4. History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
5. History of stroke.
6. Known history of any of the following genetic mutations: Factor V Leiden mutation, prothrombin mutation, antithrombin deficiency, or other thrombophilia.
7. Known or suspected carcinoma of the breast.
8. Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasm.
9. History of cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
10. History of hepatic adenomas or carcinomas.
11. Known or suspected pregnancy.
12. Smoking in women who are or will be 35 years during the course of the trial; women \<35 years who smoke 15 cigarettes or more per day must be evaluated by the investigator for inclusion based on risk factors that would increase their risk for cardiovascular disease (CVD) and thromboembolism, e.g. lipid levels, glucose level, BP, , family history of CVD at a young age. Individuals who use other forms of tobacco should be evaluated similarly by the investigator for inclusion based on the amount of tobacco use and their risk factors.
13. History of retinal vascular lesions, unexplained partial or complete loss of vision.
14. History of headaches with focal neurological symptoms (e.g., migraines with auras).
15. Impaired mobility (e.g. wheelchair bound, bed-ridden) that, in the opinion of the investigator, places the woman at increased risk of thrombosis.
Unevaluated vaginal discharge or vaginal lesions. Subjects diagnosed at screening with a chlamydia or gonococcal infection may be included in the trial following treatment completion; partner treatment is also recommended. Subjects with yeast, trichomoniasis, or bacterial vaginosis infection requiring treatment may be enrolled after treatment completion. Investigators should determine if subjects are at an elevated risk for reinfection, e.g. multiple sex partners, untreated partner, and whether such subjects can be included. Women with a history of genital herpes can be included if outbreaks are infrequent.
Have a known clinically significant Pap test abnormality, as managed by normal standard of care guidelines, that would require repeat evaluation or treatment during study participation based on the initial Pap findings.
Known benign or malignant liver tumors, renal disease or active liver disease.
Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer).
Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive.
Known or suspected current alcohol dependence, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of study product and/or study treatment compliance. A chronic marijuana user is defined as someone who uses marijuana 4 or more times per week for study purposes.
Elevated fasting clinical chemistry values or complete blood count (CBC) values designated clinically significant by the investigator or medically qualified sub-investigator.
Uncontrolled thyroid disease.
Known impaired hypothalamic-pituitary-adrenal axis.
Known hypersensitivity to silicone rubber.
History of toxic shock syndrome.
Vaginal anatomic abnormality such as cystocele or rectocele that would preclude correct use of a vaginal ring.
Planning major surgery during study participation.
Severe current constipation.
Use of liver enzyme inducers or inhibitors on a regular basis.
Known infection.
Use of any medications, including antibiotics that can significantly interfere with the metabolism of hormonal contraceptives.
Have an anticipated need for regular condom use, defined as use of at least one condom per month after enrollment.
Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.

Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Study design

Phase: Phase 2
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 385 participants (actual)

Study arms

Experimental
Regimen 1: Continuous Usage
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn continuously for 91 days.
Drug: NES-E2 CVR
Experimental
Regimen 2: Cyclical Usage
Contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR) worn for 91 days, but is removed for 2 days each month (days 29-30, 59-60, and 90-91).
Drug: NES-E2 CVR

Interventions

DrugNES-E2 CVR
NES-E2 CVR

What researchers measure

Primary outcomes

Pregnancy Rate
Time frame: 1 year

Secondary outcomes

Change in subjects' bleeding patterns for continuous vs cyclic use as compared to reported baseline bleeding patterns when the subjects were not on hormonal contraception using a bleeding questionnaire.
Time frame: 1 year
Difference in bleeding patterns for continuous vs cyclic use using a bleeding diary.
Time frame: 1 year
Incidence of adverse events, including serious adverse events
Time frame: 1 year
Summary of number of bleeding and spotting days per 30- and 90- day intervals using a bleeding diary.
Time frame: Every 30 and 90 days up to a total of 1 year
Summary of cyclic versus continuous use adverse events.
Time frame: 1 year
Summary of acceptability questionnaires.
Time frame: 1 year
Changes in complete blood count (CBC) labs from study entry (baseline)
Time frame: 1 year
Changes in fasting sodium from study entry (baseline)
Time frame: 1 year
Changes in fasting potassium from study entry (baseline)
Time frame: 1 year
Changes in fasting chloride from study entry (baseline)
Time frame: 1 year
Changes in fasting HCO3/CO2 from study entry (baseline)
Time frame: 1 year
Changes in fasting glucose from study entry (baseline)
Time frame: 1 year
Changes in fasting creatinine from study entry (baseline)
Time frame: 1 year
Changes in fasting blood urea nitrogen (BUN) from study entry (baseline)
Time frame: 1 year
Changes in fasting calcium from study entry (baseline)
Time frame: 1 year
Changes in fasting Gamma-glutamyl transferase or Gamma-glutamyl transpeptidase (GGTP) from study entry (baseline)
Time frame: 1 year
Changes in fasting protein from study entry (baseline)
Time frame: 1 year
Changes in fasting albumin from study entry (baseline)
Time frame: 1 year
Changes in fasting total bilirubin from study entry (baseline)
Time frame: 1 year
Changes in fasting direct bilirubin from study entry (baseline)
Time frame: 1 year
Changes in fasting alkaline phosphatase (ALPH) from study entry (baseline)
Time frame: 1 year
Changes in fasting Alanine Aminotransferase (ALT) from study entry (baseline)
Time frame: 1 year
Changes in fasting Aspartate Aminotransferase (AST) from study entry (baseline)
Time frame: 1 year
Changes in total cholesterol from study entry (baseline)
Time frame: 1 year
Changes in triglycerides from study entry (baseline)
Time frame: 1 year
Changes in high-density lipoprotein (HDL) from study entry (baseline)
Time frame: 1 year
Changes in low-density lipoprotein (LDL) from study entry (baseline)
Time frame: 1 year

Study locations

11 sites

Essential Access Health
Los Angeles, California 30010, United States
University of California, Davis
Sacramento, California 95817, United States
University of Colorado Denver
Aurora, Colorado 80045, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224, United States
Bellevue Hospital Center
New York, New York 10016, United States
Columbia University
New York, New York 10032, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
Oregon Health Science University
Portland, Oregon 97239, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania 19104, United States
University of Utah
Salt Lake City, Utah 84132, United States
Eastern Virginia Medical School
Norfolk, Virginia 23507, United States

References and documents

Publications

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Sitruk-Ware R. New progestagens for contraceptive use. Hum Reprod Update. 2006 Mar-Apr;12(2):169-78. doi: 10.1093/humupd/dmi046. Epub 2005 Nov 16. PubMed 16291771 ↗
Sitruk-Ware R. Pharmacological profile of progestins. Maturitas. 2008 Sep-Oct;61(1-2):151-7. doi: 10.1016/j.maturitas.2008.11.011. PubMed 19434887 ↗
Heikinheimo O, Ranta S, Moo-Young A, Lahteenmaki P, Gordon K. Parenteral administration of progestin Nestorone to lactating cynomolgus monkeys: an ideal hormonal contraceptive at lactation? Hum Reprod. 1999 Aug;14(8):1993-7. doi: 10.1093/humrep/14.8.1993. PubMed 10438416 ↗
Heikinheimo O, Noe G, Haukkamaa M, Lahteenmaki P. The progestin ST 1435--rapid metabolism in man. Contraception. 1994 Sep;50(3):275-89. doi: 10.1016/0010-7824(94)90073-6. PubMed 7805378 ↗
Kumar N, Koide SS, Tsong Y, Sundaram K. Nestorone: a progestin with a unique pharmacological profile. Steroids. 2000 Oct-Nov;65(10-11):629-36. doi: 10.1016/s0039-128x(00)00119-7. PubMed 11108869 ↗
Kumar N, Fagart J, Liere P, Mitchell SJ, Knibb AR, Petit-Topin I, Rame M, El-Etr M, Schumacher M, Lambert JJ, Rafestin-Oblin ME, Sitruk-Ware R. Nestorone(R) as a Novel Progestin for Nonoral Contraception: Structure-Activity Relationships and Brain Metabolism Studies. Endocrinology. 2017 Jan 1;158(1):170-182. doi: 10.1210/en.2016-1426. PubMed 27824503 ↗
Haukkamaa M, Laurikka-Routti M, Heikinheimo O, Moo-Young A. Contraception with subdermal implants releasing the progestin ST-1435: a dose-finding study. Contraception. 1992 Jan;45(1):49-55. doi: 10.1016/0010-7824(92)90140-o. PubMed 1591921 ↗
Fraser IS, Weisberg E, Brache V, Alvarez F, Massai R, Mishell DR Jr, Apter D, Gale J, Tsong YY, Sivin I. Serum Nestorone and ethinyl estradiol levels, and ovulation inhibition in women using three different dosage combinations of a Nestorone progestogen-ethinyl estradiol contraceptive vaginal ring on a bleeding-signaled regimen. Contraception. 2005 Jul;72(1):40-5. doi: 10.1016/j.contraception.2004.12.015. PubMed 15964291 ↗
Sivin I, Mishell DR Jr, Alvarez F, Brache V, Elomaa K, Lahteenmaki P, Massai R, Miranda P, Croxatto H, Dean C, Small M, Nash H, Jackanicz TM. Contraceptive vaginal rings releasing Nestorone and ethinylestradiol: a 1-year dose-finding trial. Contraception. 2005 Feb;71(2):122-9. doi: 10.1016/j.contraception.2004.08.010. PubMed 15707562 ↗
Weisberg E, Brache V, Alvarez F, Massai R, Mishell DR Jr, Apter D, Gale J, Sivin I, Tsong YY, Fraser IS. Clinical performance and menstrual bleeding patterns with three dosage combinations of a Nestorone progestogen/ethinyl estradiol contraceptive vaginal ring used on a bleeding-signaled regimen. Contraception. 2005 Jul;72(1):46-52. doi: 10.1016/j.contraception.2004.12.014. PubMed 15964292 ↗
Rad M, Kluft C, Menard J, Burggraaf J, de Kam ML, Meijer P, Sivin I, Sitruk-Ware RL. Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables. Am J Obstet Gynecol. 2006 Jul;195(1):72-7. doi: 10.1016/j.ajog.2005.12.007. Epub 2006 Mar 20. PubMed 16545330 ↗
Kluft C, Meijer P, LaGuardia KD, Fisher AC. Comparison of a transdermal contraceptive patch vs. oral contraceptives on hemostasis variables. Contraception. 2008 Feb;77(2):77-83. doi: 10.1016/j.contraception.2007.10.004. Epub 2008 Jan 11. PubMed 18226669 ↗
Mashchak CA, Lobo RA, Dozono-Takano R, Eggena P, Nakamura RM, Brenner PF, Mishell DR Jr. Comparison of pharmacodynamic properties of various estrogen formulations. Am J Obstet Gynecol. 1982 Nov 1;144(5):511-8. doi: 10.1016/0002-9378(82)90218-6. PubMed 6291391 ↗
Marty JP, James M, Hajo N, Wepierre J Percutaneous absorption of oestradiol and progesterone: Pharmacokinetic studies. In P Mauvais-Jarvis, CFH Vickers, J Wepierre (Eds), Percutaneous absorption of steroids. London: Academic Press Inc. (London) Ltd. 1980.
Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet. 2000 Sep;39(3):233-42. doi: 10.2165/00003088-200039030-00005. PubMed 11020137 ↗
Jensen JT, Burke AE, Barnhart KT, Tillotson C, Messerle-Forbes M, Peters D. Effects of switching from oral to transdermal or transvaginal contraception on markers of thrombosis. Contraception. 2008 Dec;78(6):451-8. doi: 10.1016/j.contraception.2008.07.004. Epub 2008 Aug 28. PubMed 19014790 ↗
Sitruk-Ware R, Plu-Bureau G, Menard J, Conard J, Kumar S, Thalabard JC, Tokay B, Bouchard P. Effects of oral and transvaginal ethinyl estradiol on hemostatic factors and hepatic proteins in a randomized, crossover study. J Clin Endocrinol Metab. 2007 Jun;92(6):2074-9. doi: 10.1210/jc.2007-0026. Epub 2007 Mar 20. PubMed 17374706 ↗
Brache V, Mishell DR, Lahteenmaki P, Alvarez F, Elomaa K, Jackanicz T, Faundes A. Ovarian function during use of vaginal rings delivering three different doses of Nestorone. Contraception. 2001 May;63(5):257-61. doi: 10.1016/s0010-7824(01)00199-8. PubMed 11448466 ↗
Odlind V, Lithell H, Selinus I, Vessby B. Unaltered lipoprotein and carbohydrate metabolism during treatment with contraceptive subdermal implants containing ST-1435. Ups J Med Sci. 1984;89(2):151-8. doi: 10.3109/03009738409178475. PubMed 6380075 ↗
Goebelsmann U, Mashchak CA, Mishell DR Jr. Comparison of hepatic impact of oral and vaginal administration of ethinyl estradiol. Am J Obstet Gynecol. 1985 Apr 1;151(7):868-77. doi: 10.1016/0002-9378(85)90664-7. PubMed 3920910 ↗
Protocol 330. Clinical Study Report on File. Population Council, New York, NY.
Archer DF, Jensen JT, Johnson JV, Borisute H, Grubb GS, Constantine GD. Evaluation of a continuous regimen of levonorgestrel/ethinyl estradiol: phase 3 study results. Contraception. 2006 Dec;74(6):439-45. doi: 10.1016/j.contraception.2006.07.005. Epub 2006 Sep 18. PubMed 17157099 ↗
Scarabin PY, Oger E, Plu-Bureau G; EStrogen and THromboEmbolism Risk Study Group. Differential association of oral and transdermal oestrogen-replacement therapy with venous thromboembolism risk. Lancet. 2003 Aug 9;362(9382):428-32. doi: 10.1016/S0140-6736(03)14066-4. PubMed 12927428 ↗
Belsey EM, Machin D, d'Arcangues C. The analysis of vaginal bleeding patterns induced by fertility regulating methods. World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1986 Sep;34(3):253-60. doi: 10.1016/0010-7824(86)90006-5. PubMed 3539509 ↗
Merkatz RB, Plagianos M, Hoskin E, Cooney M, Hewett PC, Mensch BS. Acceptability of the Nestorone(R)/ethinyl estradiol contraceptive vaginal ring: development of a model; implications for introduction. Contraception. 2014 Nov;90(5):514-21. doi: 10.1016/j.contraception.2014.05.015. Epub 2014 Jun 2. PubMed 24993487 ↗
Isidori AM, Pozza C, Esposito K, Giugliano D, Morano S, Vignozzi L, Corona G, Lenzi A, Jannini EA. Development and validation of a 6-item version of the female sexual function index (FSFI) as a diagnostic tool for female sexual dysfunction. J Sex Med. 2010 Mar;7(3):1139-46. doi: 10.1111/j.1743-6109.2009.01635.x. Epub 2009 Dec 1. PubMed 19968774 ↗
Borch KH, Braekkan SK, Mathiesen EB, Njolstad I, Wilsgaard T, Stormer J, Hansen JB. Anthropometric measures of obesity and risk of venous thromboembolism: the Tromso study. Arterioscler Thromb Vasc Biol. 2010 Jan;30(1):121-7. doi: 10.1161/ATVBAHA.109.188920. Epub 2009 Oct 15. PubMed 19834110 ↗
Pomp ER, le Cessie S, Rosendaal FR, Doggen CJ. Risk of venous thrombosis: obesity and its joint effect with oral contraceptive use and prothrombotic mutations. Br J Haematol. 2007 Oct;139(2):289-96. doi: 10.1111/j.1365-2141.2007.06780.x. PubMed 17897305 ↗
Simmons KB, Kumar N, Plagianos M, Roberts K, Hoskin E, Han L, Alami M, Creasy G, Variano B, Merkatz R. Effects of concurrent vaginal miconazole treatment on the absorption and exposure of Nestorone(R) (segesterone acetate) and ethinyl estradiol delivered from a contraceptive vaginal ring: a randomized, crossover drug-drug interaction study. Contraception. 2018 Mar;97(3):270-276. doi: 10.1016/j.contraception.2017.10.010. Epub 2017 Oct 31. PubMed 29097225 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03432416
Lead sponsor: Premier Research
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Population Council
Responsible party: Sponsor
First posted: Feb 14, 2018
Start date: Feb 12, 2018
Primary completion: Aug 28, 2021
Completion: Dec 14, 2021
Last update: Oct 31, 2025

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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