Last reviewed · How we verify
NCT00001454
Hormonal Effects on the Uterus and Endometrium
trial in Pregnancy in 129 participants. Completed in 27 July 2015.
Quick facts
| Lead sponsor | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 129 |
| Start date | 21 April 1995 |
| Estimated completion | 27 July 2015 |
| Sites | 1 location across United States |
Conditions studied
- Pregnancy — all drugs for Pregnancy →
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Who can join
Adults 18 to 43, female only, with Pregnancy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Endometrium is the lining of the uterus. It is where the fertilized egg normally implants during pregnancy. This study was designed to better understand the way(s) that female sex hormones (estrogen and progesterone) cause the uterus to grow and develop. It is known that these hormones are necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown. Researchers would like to identify the genes that are affected by female sex hormones by using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human endometrium). Researchers will select women who have regular monthly menstrual cycles and study them for two cycles; 1. \<TAB\>The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's body temperature and progesterone measurements during the last 14 days (luteal phase) of the menstrual cycle. 2. \<TAB\> The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone that causes the ovary to release the developed egg. Ovarian ultrasounds will be performed before the biopsy to determine development of the egg. Blood tests will be taken on the day of the biopsy to have an overall idea of the hormones circulating in the patient's blood. An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen, estrogen/progesterone, or steroid hormone withdrawal.\<TAB\>
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00001454
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) trials
Trials by the same sponsor.
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- 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
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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 NCT00001454 (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: 16 December 2019
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/NCT00001454.
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