Last reviewed · How we verify
NCT00000466
Postmenopausal Estrogen/Progestin Interventions (PEPI)
Phase 3 trial testing estrogens, conjugated in Bone Diseases. Completed in 1 October 2000.
Quick facts
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Masking | double |
| Primary purpose | prevention |
| Start date | 1 September 1987 |
| Estimated completion | 1 October 2000 |
Drugs / interventions tested
- estrogens, conjugated — full drug profile →
- medroxyprogesterone
- progesterone (Progesterone plus HCG) — full drug profile →
- estrogen replacement therapy
Conditions studied
- Bone Diseases — all drugs for Bone Diseases →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
- Coronary Disease — all drugs for Coronary Disease →
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Who can join
Adults 45 to 64, female only, with Bone Diseases or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To assess the effects of various postmenopausal estrogen replacement therapies on selected cardiovascular risk factors, including high density lipoprotein cholesterol, systolic blood pressure, fibrinogen, and insulin and on osteoporosis risk factors. Conducted in collaboration with the National Institute of Child Health and Human Development, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, The National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute on Aging. The extended follow-up is for 3 years focusing on endometrium and breast evaluation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Bone-density testing interval and transition to osteoporosis in older women.
Gourlay ML, Fine JP, Preisser JS, May RC, et al · · 2012 · cited 180× · PMID 22256806 · DOI 10.1056/nejmoa1107142
Verify or expand the search:
- PubMed search for NCT00000466
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bone Diseases
Currently open trials in the same condition.
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Other National Heart, Lung, and Blood Institute (NHLBI) trials
Trials by the same sponsor.
- NCT07566494 — Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease · Phase 1 · not yet recruiting
- NCT07137455 — EDEN Intracardiac Electrogram Recording and Classifying System · NA · enrolling by invitation
- NCT05372627 — NHLBI-Emory Advanced Cardiac CT Reconstruction · not yet recruiting
- NCT07516379 — GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejecti · not yet recruiting
- NCT06948097 — Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fost · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00000466 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
- Last refreshed: 12 May 2016
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/NCT00000466.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing