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Progesterone + Testosterone for Long QT Syndrome
Phase 4
Recruiting
Led By James E Tisdale, PharmD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Postmenopausal (have not had a menstrual period for 12 months or longer)
Older Men: Age 65 years old to 99 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
Awards & highlights
Study Summary
This trial will study the effects of progesterone and testosterone on QT interval lengthening in postmenopausal women and men over 65.
Who is the study for?
This trial is for postmenopausal women aged 50-99 and men aged 65-99 without certain health conditions like severe anemia, heart issues, or a history of specific cancers. Participants should not be on hormone replacement therapy or drugs that affect heart rhythm.Check my eligibility
What is being tested?
The study tests if progesterone in women and testosterone in men can reduce changes to the heart's electrical activity caused by ibutilide, a drug known to lengthen the QT interval. It's a controlled experiment where participants randomly receive either the hormone treatment or placebo.See study design
What are the potential side effects?
Possible side effects include hormonal changes such as mood swings or weight gain for both treatments. Ibutilide may cause cardiac arrhythmias, which are irregularities in heartbeat rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had a menstrual period for at least 12 months.
Select...
I am a man aged between 65 and 99.
Select...
I am a woman aged 50-99 and have gone through menopause.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~adverse effects will be assessed via telephone calls to subjects between days 2 and 4 and between days 5 and 7 of oral progesterone and oral placebo
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Area under the J-Tpeakc versus time curve during and for 8 hours following ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
+12 moreOther outcome measures
Adverse effects of ibutilide
Adverse effects of oral progesterone and placebo
Adverse effects of transdermal testosterone and transdermal placebo
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Postmenopausal women: ProgesteroneExperimental Treatment2 Interventions
Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Group II: Men 65 years of age or older: TestosteroneExperimental Treatment2 Interventions
Subjects will receive treatment with transdermal testosterone 1% (100 mg) every morning for 3 days
Group III: Men 65 years of age or older: PlaceboPlacebo Group2 Interventions
Subjects will receive treatment with transdermal placebo every morning for 3 days
Group IV: Postmenopausal women: PlaceboPlacebo Group2 Interventions
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Progesterone
2013
Completed Phase 4
~4510
Ibutilide
2013
Completed Phase 4
~240
Testosterone
2009
Completed Phase 4
~2020
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,413 Total Patients Enrolled
8 Trials studying Long QT Syndrome
7,763 Patients Enrolled for Long QT Syndrome
Harvard UniversityOTHER
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474,500 Total Patients Enrolled
Cedars-Sinai Medical CenterOTHER
499 Previous Clinical Trials
164,774 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking medication that can affect my heart's rhythm.My heart's electrical activity reading (QTc) is over 450 ms.I am an older man diagnosed with heart failure.I am a postmenopausal woman and have had heart rhythm problems that needed treatment.I am a postmenopausal woman who has had a heart attack.I am a man with a history of heart rhythm problems not caused by a heart attack.I have not had a menstrual period for at least 12 months.I am a postmenopausal woman diagnosed with heart failure.I am a postmenopausal woman and I am currently taking medication that strongly affects liver enzymes.I am currently using medication that affects liver enzymes.I am a postmenopausal woman with a history of long QT syndrome or sudden cardiac death not due to a heart attack.I am currently using medication that strongly affects liver enzyme activity.Women who have gone through menopause: have low levels of magnesium in the blood at the time of the screening visit.I am a postmenopausal woman weighing more than 135 kg.I am a postmenopausal woman with a hematocrit level below 26%.My potassium level is below 3.6 mEq/L before taking ibutilide.I am a man weighing less than 60 kg at the time of screening.I have been diagnosed with an enlarged prostate.My heart's electrical activity takes longer than normal.I am a man with a family history of sudden heart issues not caused by a heart attack.My heart rhythm is controlled by a pacemaker.I am a man aged between 65 and 99.I am a postmenopausal woman with a family history of sudden heart issues not related to a heart attack.My magnesium level is below 1.8 mg/dL.I am a postmenopausal woman and I am taking hormone replacement therapy.I am a postmenopausal woman with a history of breast, uterine, or ovarian cancer.I am a postmenopausal woman weighing less than 60 kg.I am a postmenopausal woman and I am not taking any drugs that affect liver enzymes.I am a man with a history of breast or prostate cancer.I am a postmenopausal woman with a history of heart disease.I am a postmenopausal woman with liver enzyme levels more than three times the normal limit.I am a postmenopausal woman and I am currently taking medication that can affect my heart's rhythm.I am a postmenopausal woman with a permanent pacemaker.My blood's hematocrit level is below 26%.I am a postmenopausal woman who has had a hysterectomy or ovariectomy.I am a man weighing more than 135 kg.I am a woman aged 50-99 and have gone through menopause.I have a heart rhythm problem detected before starting the study.My liver enzymes are more than three times the normal limit.Women who have gone through menopause should not have low potassium levels when receiving ibutilide.I am a postmenopausal woman with a QTc over 450 ms.I am a postmenopausal woman with a QRS duration over 120 ms.I am a postmenopausal woman with a history of irregular heart rhythms.
Research Study Groups:
This trial has the following groups:- Group 1: Men 65 years of age or older: Testosterone
- Group 2: Men 65 years of age or older: Placebo
- Group 3: Postmenopausal women: Progesterone
- Group 4: Postmenopausal women: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is participation in this clinical trial open?
"This experiment is recruiting 83 post-menopausal individuals aged between 50 and 85 with a diagnosis of long qt syndrome. Qualifying participants must have not had a menstrual period in the past 12 months or more."
Answered by AI
What is the current enrollment size for this clinical trial?
"Affirmative, clinicaltrials.gov data indicates that this investigation is presently recruiting volunteers; the posting was made on September 2nd 2021 and lastly updated August 3rd 2022. The research requires 83 individuals from three distinct sites to participate."
Answered by AI
Are researchers currently recruiting participants to join this experiment?
"As indicated on clinicaltrials.gov, enrolment for this medical trial is ongoing and has been since it was initial posted on September 2nd 2021. The latest update to the study took place on August 3rd 2022."
Answered by AI
What is the standard utilization of Progesterone?
"Progesterone is often utilized to prevent premature labor and delivery. It has also been found beneficial in tackling issues such as vanishing testis syndrome, female infertility, and gel formation."
Answered by AI
Is this experiment available to adults below the age of 45?
"According to the requirements of this clinical trial, participants must be aged 50-85."
Answered by AI
To what extent could Progesterone be considered perilous to individuals?
"Our team at Power have appraised the safety of Progesterone to be a 3 due to its Phase 4 status, signifying that it has been sanctioned for therapeutic use."
Answered by AI
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