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Hormone Therapy

Progesterone for Long QT Syndrome

Phase 4

Waitlist Available

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 women: 50 years of age or older and no menstrual periods for 365 days or longer

Premenopausal women: 21-40 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours after the ibutilide infusion

Awards & highlights

Study Summary

This trial will test whether taking progesterone capsules can help prevent drug-induced lengthening of the QT interval in postmenopausal and premenopausal women.

Who is the study for?

This trial is for postmenopausal women aged 50+ without periods for over a year, and premenopausal women aged 21-40. Participants must not have heart failure, cancer history, severe edema or breathlessness on exertion, certain abnormal ECG rhythms, use of QT-prolonging drugs or hormonal contraceptives, be pregnant or exceed weight limits.Check my eligibility

What is being tested?

The study tests if oral progesterone can prevent QT interval lengthening (a type of heart rhythm disturbance) caused by the drug ibutilide. Women will take either progesterone or a placebo in two phases with a washout period in between. The effect on their heart's electrical activity is compared after each phase.See study design

What are the potential side effects?

Potential side effects from progesterone may include mood swings, headaches, bloating and breast tenderness. Ibutilide might cause further QT interval lengthening which can lead to serious irregular heartbeat risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 50 and have not had a period for at least a year.

Select...

I am a premenopausal woman aged between 21 and 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to ibutilide; at 5 minutes into the 10-minute ibutilide infusion; end of infusion; and at 5, 10, 15, 20, 30, and 45 minutes and 1 hour after the ibutilide infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

% change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals

Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion

Area under the QT-F and QT-Fram versus time curves during and for 8 hours following ibutilide infusion

+2 more

Secondary outcome measures

% change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals

% change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals

Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion

+7 more

Other outcome measures

Adverse effects

Side effects data

From 2018 Phase 4 trial • 64 Patients • NCT02255175

18%

Breast Tenderness

15%

Cramps

15%

Itchiness at patch site

12%

Headaches

Nausea

Acne

Lower Back Pain

Hot Flashes

Menstrual Bleeding

Bloating

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Perimenopausal Women, Depressed

Perimenopausal Women, Non-depressed

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Premenopausal 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: 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 III: Postmenopausal women: PlaceboPlacebo Group1 Intervention

Subjects will receive oral placebo, two capsules once daily every evening for 7 days

Group IV: Premenopausal women: PlaceboPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,966 Total Patients Enrolled

3 Trials studying Long QT Syndrome

116 Patients Enrolled for Long QT Syndrome

American Heart AssociationOTHER

326 Previous Clinical Trials

4,933,814 Total Patients Enrolled

2 Trials studying Long QT Syndrome

33 Patients Enrolled for Long QT Syndrome

Purdue UniversityOTHER

224 Previous Clinical Trials

72,748 Total Patients Enrolled

2 Trials studying Long QT Syndrome

97 Patients Enrolled for Long QT Syndrome

Media Library

Long QT Syndrome Research Study Groups: Postmenopausal women: Progesterone, Postmenopausal women: Placebo, Premenopausal women: Progesterone, Premenopausal women: Placebo

Long QT Syndrome Clinical Trial 2023: Progesterone Highlights & Side Effects. Trial Name: NCT03834883 — Phase 4

Progesterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03834883 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Progesterone obtained authorization from the FDA?

"The safety of progesterone, which is approved for use by the FDA, was judged to be a 3 on our team's scale."

Answered by AI

Are there any opportunities for participants to join this research project at present?

"The information found on clinicaltrials.gov confirms that this trial is currently seeking participants; the study was initially published in March of 2019 and has been revised as recently as August 3rd 2022."

Answered by AI

What primary goal is this clinical experiment attempting to prove?

"The primary goal of this trial, which will be monitored over a period near the start and end of ibutilide infusion; plus 5, 10, 15, 20, 30 and 45 minutes in; as well as 1, 2, 4 6 and 8 hours afterwards is to record baseline QT-F and Tpeak-Fram intervals. Secondary objectives involve ascertaining Area under J-Tpeakc versus time curves throughout one hour after ibutilide administration; measuring % transformation from pre-ibutilide maximum Tpeak - Tend intervals; and estimating Area beneath the Tpeak - Tend against time curves during an hour following ibutilide application"

Answered by AI

Are there any additional investigations that have been done regarding Progesterone?

"Currently, 42 medical trials are studying the properties of Progesterone with 8 being in their final phase. While Barcelona, Catalunya has a particularly high concentration of clinical trials for this drug, there are 268 sites across the world enrolled in these studies."

Answered by AI

In what ways is Progesterone primarily administered?

"Progesterone is frequently administered to treat infertility in women; this hormone has also been known to alleviate symptoms of endometriosis, postmenopause, and recurrent spontaneous preterm birth."

Answered by AI

How many participants are being administered medication in this experiment?

"Affirmative. According to information provided on clinicaltrials.gov, this medical experiment is presently enrolling participants; the trial was originally posted on March 26th 2019 and has been newly updated as of August 3rd 2022. 40 individuals are needed from a single site for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing the Risk of Drug-Induced QT Interval Lengthening in Women

James E. Tisdale 2019. "Reducing the Risk of Drug-Induced QT Interval Lengthening in Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834883.

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