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Trial · Interventional

CompletedNot applicableRegistry data

Menopause Effects on Vascular Function

NCTNCT03236545 (opens ClinicalTrials.gov in a new tab)Other id385453-18
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Ganirelix, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Not applicable
Enrollment
48 participants (actual)
Sponsor
University of Delaware · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Jul 2016
Primary completion
30 Apr 2022
Completion
1 Nov 2022
First posted
2 Aug 2017
Last update posted
14 Nov 2022
Conditions
Cardiovascular Risk Factor

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201820202022
  1. N/A

    Menopause Effects on Vascular Function

    NCT03236545

    1 Jul 2016 to 1 Nov 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to identify the independent effect of estradiol (E2) on endothelin-1 (ET-1) mediated vasomotor function in women. The study is the first step in recognizing the impact of ovarian hormones on the mechanisms that regulate vascular function in women to provide a better understanding of the cardiovascular efficacy of hormone therapy.

Interventions

  • No to Low Endogenous EstrogenOther
  • EstradiolOther

Arms2

  • Experimental

    No to Low Endogenous Estrogen

    PMW and young women (YW) will receive medical study clearance after a detailed physical examination. YW will self-administer subcutaneous injections of the gonadotropin-releasing hormone (GnRH) antagonist, ganirelix acetate (Antagon, 0.25 mg/day in 0.5 ml of normal saline, Organon, Inc., West Orange, New Jersey,) daily to suppress endogenous ovarian hormone production (16, 17, 18). This will begin following a separate medical screening at Reproductive Associates of Delaware 48 hours prior to initiating the hormone intervention to rule out other contraindications prior to beginning the treatment. YW will begin using the antagonist on days 26-28 of their menstrual cycle, and continue daily for 10-12 days. The experimental protocol will be conducted in YW after 3-4 days of using the GnRH antagonist. PMW will complete the experimental protocol prior to use of the 17β-estradiol (E2, 0.1 mg/day patch, Vivelle dot; estradiol patch).

  • Experimental

    Estrogen Add-Back

    Estradiol (E2, 0.1 mg/day patch, Vivelle dot; estradiol patch) will be administered for 7 days to both young and PMW. Young women will use the E2 over the last 7 days of Antagon administration.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Vascular endothelial function

    Time frame · 3 years

    Registry description

    The capacity of the small and large blood vessels to dilate.

Secondary outcomes(1)

  1. Endothelin receptor expression

    Time frame · 3 years

    Registry description

    Venous endothelial cells and skin punch biopsy will be collected and stained for ET-A and ET-B receptor expression

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 1999

8 results

Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part I. Absolute bioavailability of 0.25 mg of ganirelix after a single subcutaneous injection in healthy female volunteers.

Oberyé et al. 1999Fertility and sterilitycited by 51

PMID 10593371DOI 10.1016/s0015-0282(99)00413-6PUB-10593371

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 1999

13 results

Pharmacokinetic and pharmacodynamic characteristics of ganirelix (Antagon/Orgalutran). Part II. Dose-proportionality and gonadotropin suppression after multiple doses of ganirelix in healthy female volunteers.

Oberyé et al. 1999Fertility and sterilitycited by 80

PMID 10593372DOI 10.1016/s0015-0282(99)00414-8PUB-10593372

Full text at the publisher13 results
Publisher pageSee results (13)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Young women between 18-35 years of age with regular menstrual cycles * Postmenopausal women between 50-65 years of age and no more than 10 years past menopause * Non-smoking * BMI \< 30 kg/m2 * Free from known disease (heart disease, cancer, diabetes) Exclusion Criteria: * Current use of hormone therapy or within the past year * Women using Depo-provera or an intra-uterine device (IUD) * Pregnant, are planning on becoming pregnant, or are breast- feeding. * History of stable or unstable angina * Diabetes * Neurological disease * Lung disease * Kidney or liver disease * Cancer * Hysterectomy * Peripheral vascular disease * History of blood clots * Heart disease * Fibroids * High blood pressure * Stroke

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