Who is sponsoring NCT03815929?

NCT03815929 is sponsored by Mayo Clinic.

What drugs are being tested in NCT03815929?

Interventions in NCT03815929: Estradiol 100 Micrograms Patch, Estradiol Patch.

What condition does NCT03815929 study?

NCT03815929 studies Cardiovascular Risk Reduction.

Is NCT03815929 still recruiting?

NCT03815929 is currently completed. Last updated 23 October 2024.

Are results published for NCT03815929?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-23 · How we verify

NCT03815929

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

Oophorectomy, Estrogen Therapy and Cardiovascular Disease Risk in Young Women

Completed Phase 2 Results posted Last updated 23 October 2024

What this trial tests

Phase 2 trial testing Estradiol 100 Micrograms Patch in Cardiovascular Risk Reduction in 35 participants. Completed in 28 August 2023.

Timeline

15 March 2019

Primary endpoint
28 August 2023

28 August 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	35
Start date	15 March 2019
Primary completion	28 August 2023
Estimated completion	28 August 2023
Sites	1 location across United States

Drugs / interventions tested

Estradiol 100 Micrograms Patch — full drug profile →
Estradiol Patch — full drug profile →

Conditions studied

Cardiovascular Risk Reduction — all drugs for Cardiovascular Risk Reduction →

Sponsor

Mayo Clinic

Who can join

Adults 21 to 45, female only, with Cardiovascular Risk Reduction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Arterial Stiffness Primary · Baseline, 6 months, and 12 months

Augmented pressure, a measure of arterial stiffness was recorded through high-fidelity pressure waveforms and compared at planned time frames

Baseline augmented pressure

Group	Value	95% CI
Standard Replacement Therapy Regimen	10.1	± 6.9
Titrated Replacement Therapy Regimen	14.8	± 4.3
Timed Control Group	6.4	± 3.7

6 months augmented pressure

Group	Value	95% CI
Standard Replacement Therapy Regimen	12.7	± 6.0
Titrated Replacement Therapy Regimen	16.8	± 6.4
Timed Control Group	5.1	± 3.1

12 months augmented pressure

Group	Value	95% CI
Standard Replacement Therapy Regimen	12.9	± 6.7
Titrated Replacement Therapy Regimen	17.3	± 7.2
Timed Control Group	6.5	± 4.0

Mean Blood Pressure Reactivity to Isometric Hand Grip Exercise Secondary · Baseline, 6 months, and 12 months

Change in mean blood pressure in response to isometric hand grip exercise (30% maximum voluntary contraction)

baseline mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	11.6	± 4.6
Titrated Replacement Therapy Regimen	11.4	± 5.9
Timed Control Group	8.3	± 3.5

6-month mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	11.7	± 5.0
Titrated Replacement Therapy Regimen	15.3	± 5.3
Timed Control Group	10.7	± 2.6

12-month mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	16.2	± 7.1
Titrated Replacement Therapy Regimen	12.4	± 7.6
Timed Control Group	13.9	± 9.9

Mean Blood Pressure Reactivity to Cold Stress Secondary · Baseline, 6 months, and 12 months

Maximum change in mean blood pressure during 3-minute cold pressor test (immersing hand up to wrist in ice water while changes in blood pressure monitored)

Baseline mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	22	± 10
Titrated Replacement Therapy Regimen	20	± 9
Timed Control Group	20	± 8

6-month mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	21	± 13
Titrated Replacement Therapy Regimen	25	± 9
Timed Control Group	18	± 5

12-month mean blood pressure reactivity

Group	Value	95% CI
Standard Replacement Therapy Regimen	26	± 12
Titrated Replacement Therapy Regimen	25	± 7
Timed Control Group	17	± 3

Changes in Whole Body Fat Secondary · Baseline and 12 months

Measurements of whole-body fat using Dual energy x-ray absorptiometry (DXA)

Baseline total body fat

Group	Value	95% CI
Standard Replacement Therapy Regimen	30712	± 12958
Titrated Replacement Therapy Regimen	43363	± 26212
Timed Control Group	199936	± 14221

12-month total body fat

Group	Value	95% CI
Standard Replacement Therapy Regimen	31868	± 18020
Titrated Replacement Therapy Regimen	42660	± 25938
Timed Control Group	16735	± 3114

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Replacement Therapy Regimen

Serious: 2/15 (13%)

Deaths: 0/15

Titrated Replacement Therapy Regimen

Serious: 2/15 (13%)

Deaths: 0/15

Timed Control Group

Serious: 0/5 (0%)

Deaths: 0/5

Serious adverse events (4 terms)

Reaction	System	Standard Replacement Thera…	Titrated Replacement Thera…	Timed Control Group
Intestinal obstruction	Gastrointestinal disorders	—	—	—
Sinus tachycardia of unknown etiology after planned oophorectomy & liver procedure	Cardiac disorders	—	—	—
Liver Infarct (extended hospital stay)	General disorders	—	—	—
non-focal Bile leak from disease resection (extended hospital stay)	General disorders	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Standard Replacement Thera…	Titrated Replacement Thera…	Timed Control Group
Rash at patch site	General disorders	—	—	—
Passed out after blood draw at CRTU	General disorders	—	—	—
Moderate bilateral pleural effusion	General disorders	—	—	—
Ovarian Cancer Stage IIIc high grade Serious Carcinoma	General disorders	—	—	—
COVID 19	General disorders	—	—	—
Decreased Libido	General disorders	—	—	—
Bladder Issues	General disorders	—	—	—
Headache/vomitting/allergic reaction to MRI	General disorders	—	—	—
Vaginal cuff dehiscence	Reproductive system and breast disorders	—	—	—
Pain with intercourse, vaginal dryness, and low sex drive	Reproductive system and breast disorders	—	—	—
Migraine with vomitting during blood pressure regulation baseline testing	General disorders	—	—	—
Itching from patch site	General disorders	—	—	—
Vaginal cuff dehiscence with infection	Reproductive system and breast disorders	—	—	—
Estradiol gives burnt taste in mouth	General disorders	—	—	—

Most-reported serious reactions: Intestinal obstruction, Sinus tachycardia of unknown etiology after planned oophorectomy & liver procedure, Liver Infarct (extended hospital stay), non-focal Bile leak from disease resection (extended hospital stay).

Data from ClinicalTrials.gov NCT03815929 adverse events section.

Sponsor's own description

Researchers are trying to assess the appropriate dose of estrogen for decreasing the risk of cardiovascular disease in women who have removal of their ovaries at a young age, before the age of 46 years.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03815929 (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 Mayo Clinic
Last refreshed: 23 October 2024

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/NCT03815929.

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