NCT00370019 is a Phase 2 clinical trial of Estradiol/Medroxyprogesterone acetate in Premature Ovarian Failure, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

What drugs are being tested in NCT00370019?

Interventions in NCT00370019: Estradiol/Medroxyprogesterone acetate.

What condition does NCT00370019 study?

NCT00370019 studies Premature Ovarian Failure.

Is NCT00370019 still recruiting?

NCT00370019 is currently withdrawn. Last updated 2 July 2017.

Last reviewed 2017-07-02 · How we verify

NCT00370019

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of an Estrogen Replacement Therapy Skin Patch on Ovulation in Women With Premature Ovarian Failure

Withdrawn Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Estradiol/Medroxyprogesterone acetate in Premature Ovarian Failure. Withdrawn.

Timeline

25 August 2006

Primary endpoint
12 December 2011

12 December 2011

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Primary purpose	treatment
Start date	25 August 2006
Primary completion	12 December 2011
Estimated completion	12 December 2011
Sites	1 location across United States

Drugs / interventions tested

Estradiol/Medroxyprogesterone acetate

Conditions studied

Premature Ovarian Failure — all drugs for Premature Ovarian Failure →

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Who can join

Adults 18 to 40, female only, with Premature Ovarian Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine whether giving estrogen replacement therapy through an estradiol patch can improve ovulation rates in women with spontaneous premature ovarian failure. The ovaries are glands in women that produce female hormones and normally release an egg once a month. In women with spontaneous premature ovarian failure, the ovaries stop working too soon. Women with this disorder have abnormally high levels of leuteinizing hormone (LH) in their blood, which impedes normal ovulation. In some women, estrogen replacement can suppress LH levels to the normal range. Women between 18 and 40 years of age with premature ovarian failure may be eligible for this 4-month study. Participants receive either standard hormone replacement therapy, consisting of an estradiol patch and progestin tablets, or placebo. The placebo group receives patches and tablets that look the same as those for the group with active treatment but they contain no hormone. All participants wear the patch every day and take the tablets the first 12 days of each month. In addition to taking the study drug, participants have blood drawn once a week for the 16 weeks of the study. At the end of the trial, women who were in the placebo group are offered the opportunity to receive the estrogen patch and progestin therapy for another 16 weeks and continue the blood tests to determine if they ovulate on this treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Premature Ovarian Failure

Currently open trials in the same condition.

NCT05740579 — The Danish TURNER Cryopreservation Study · NA · recruiting
NCT05462379 — Autologous Heterotopic Fresh Ovarian Graft in Woman With LACC Eligible for Pelvic Radiotherapy Treatment. · Phase 1, PHASE2 · active not recruiting
NCT04815213 — The Use of Expandeded Mesenchymal Stromal Cells (MSC) in Premature Ovarian Failure (POF) in Adult Humans · Phase 1 · active not recruiting
NCT04390308 — Is There A Role For Mechanical Stimulation In Ovarian Follicular Activation? · recruiting
NCT04381299 — Will Autologous Platelet Rich Plasma Able To Restore Ovarian Function? · active not recruiting

Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials

Trials by the same sponsor.

NCT07502586 — Turner Syndrome: Genetic Considerations · recruiting
NCT07357701 — Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI) · recruiting
NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
NCT05548881 — Implications of Maternal 45,X Mosaicism as a Secondary Genomic Finding Following Cell-Free DNA Sequencing During Pregnan · withdrawn
NCT06749366 — Uncovering Genes Behind Cartilage Tumors and Vascular Anomalies Using Genomic Sequencing · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00370019 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last refreshed: 2 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00370019.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing