Progesterone for Abnormalities, Drug-Induced

Phase-Based Estimates
3
Effectiveness
3
Safety
Indiana University, Indianapolis, IN
Abnormalities, Drug-Induced+1 More
Progesterone - Drug
Eligibility
18+
Female
Eligible conditions
Abnormalities, Drug-Induced

Study Summary

This study is evaluating whether progesterone may help reduce the risk of abnormal heart rhythms in women.

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Eligible Conditions

  • Abnormalities, Drug-Induced
  • Long QT Syndrome

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Progesterone will improve 5 primary outcomes, 10 secondary outcomes, and 1 other outcome in patients with Abnormalities, Drug-Induced. Measurement will happen over the course of After 7 days of treatment with oral progesterone or placebo, prior to receiving ibutilide.

Day 7
Baseline (pre-ibutilide) QT-F and QT-Fram intervals
Baseline (pre-ibutilide) Tpeak-Tend intervals
Baseline (pre-ibutilide) heart rate-corrected J-Tpeak (J-Tpeakc) intervals
Day 7
Adverse effects
Hour 1
Area under the J-Tpeakc versus time curve during and for 1 hour following ibutilide infusion
Area under the QT-F and QT-Fram versus time curves during and for 1 hour following ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 1 hour following ibutilide infusion
Hour 8
% change from baseline (pre-ibutilide) in maximum J-Tpeakc intervals
% change from baseline (pre-ibutilide) in maximum QT-F and QT-Fram intervals
% change from baseline (pre-ibutilide) maximum Tpeak-Tend intervals
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 8 hours following ibutilide infusion
Area under the Tpeak-Tend versus time curves during and for 8 hours following ibutilide infusion
Maximum post-ibutilide J-Tpeakc intervals
Maximum post-ibutilide QT-F and QT-Fram intervals
Maximum post-ibutilide Tpeak-Tend intervals

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

4 Treatment Groups

Postmenopausal women: Placebo
Postmenopausal women: Progesterone
Placebo group

This trial requires 40 total participants across 4 different treatment groups

This trial involves 4 different treatments. Progesterone is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Postmenopausal women: ProgesteroneSubjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Premenopausal women: ProgesteroneSubjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days
Postmenopausal women: Placebo
Drug
Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Premenopausal women: Placebo
Drug
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
Ibutilide
FDA approved
Progesterone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during the 7 days of treatment with progesterone/placebo and 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
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during the 7 days of treatment with progesterone/placebo and 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 for reporting.

Who is running the study

Principal Investigator
J. E. T.
Prof. James E. Tisdale, Professor, College of Pharmacy, Purdue University
Indiana University

Closest Location

Indiana University - Indianapolis, IN

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Individuals who are 50 years of age or older are eligibile to receive the shingles vaccine. show original
This person has not had a menstrual period for 365 days or longer. show original
- Adults - Persons Adults in the 21-40 year old range are persons. show original

Patient Q&A Section

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

What are common treatments for abnormalities, drug-induced?

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Abnormalities that occur as side effects of drugs are commonly treated with drugs with antipsychotic, anti-HIV or antiepileptic properties. Abnormalities that occur only with the use of the drugs are treated with medications with antiepileptic, anti-HIV or antidepressant properties.

Unverified Answer

How many people get abnormalities, drug-induced a year in the United States?

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The number of abnormalities, drug-induced, is increasing among patients and has already caused more hospitalizations and longer hospitalizations. This could be a result of more prevalent and earlier detection due to technological advances and advances in disease-specific treatment. Drug-induced abnormalities are associated with increased hospital morbidity and resource usage, and patients are usually hospitalized after a drug interaction has caused a reaction that requires hospitalization.

Unverified Answer

What causes abnormalities, drug-induced?

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Drug-induced abnormalities most often result from substance use, or from drug and alcohol interactions with prescription or herbal medicines, which may adversely affect the central nervous system. In many cases, a positive drug-test result alone or with other symptoms results in increased suspicion. When a careful medical history and physical are obtained with the use of specific objective diagnostic methods, such as electro-encephalogram (EEG), magnetic resonance imaging (MRI), and radionuclide imaging, the causes of certain abnormalities can be identified.

Unverified Answer

What is abnormalities, drug-induced?

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Abnormalities, particularly if not associated with other drugs or side effects can be indicative of drug-induced toxicities. Abnormalities usually occur early during treatment and resolve without further investigation.

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Can abnormalities, drug-induced be cured?

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If abnormalities can be detected early, and the cause can be identified, abnormalities can often be cured. Most often, this will be after years of abnormal function, but some such as polycythemia can sometimes be cured even when asymptomatic at diagnosis. If asymptomatic, patients with polycythemia or polycytosis must be monitored closely for any progression into polycythemia vera syndrome.

Unverified Answer

What are the signs of abnormalities, drug-induced?

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There are many different medical conditions that can cause symptoms and abnormalities. The abnormalities may vary from small amounts of fluid to large amounts of fluid, from a change in bodily function to a complete loss of bodily function. Abnormalities can sometimes be detected on an abnormal clinical laboratory test. The signs of a condition may be the first to appear or may be more severe when compared to an signs or symptoms. While an abnormality or symptom is present, a patient may be asymptomatic.

Unverified Answer

Has progesterone proven to be more effective than a placebo?

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Progestone is an effective agent for the treatment of DHEA-resistant IGT. However, in a randomized controlled trial, no significant difference between treatment and placebo was achieved. The trial was not large enough to permit meaningful conclusions to be drawn concerning the effect of progesterone.

Unverified Answer

Does progesterone improve quality of life for those with abnormalities, drug-induced?

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Although some treatments for PE improved HRQoL, the use of progesterone alone showed no significant improvement. This trial demonstrates that progesterone could be used in clinical trials for PE.

Unverified Answer

How serious can abnormalities, drug-induced be?

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If any abnormalities, presumably drug-induced, were seen, they were most often transient with normalization without intervention. If an abnorm, presumably drug-induced, was not seen following 3 months' regular use, such as in a chronic state, it is of concern and could lead to further testing that should be addressed by a medical professional.

Unverified Answer

What is progesterone?

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Prolactin promotes the migration of epithelial cells in all areas of the uterus and in the fallopian tubes. The effects are mediated by estrogen receptors. If there are circulating or pituitary hormones present, this causes an increase in progesterone receptors, which in turn is likely to cause a further increase in expression of the receptors. Although endogenous progesterone plays significant roles in the menstrual cycle, pregnancy, and implantation in some female mammals, it is less important in human reproduction than estradiol, the major female sex hormone for reproduction. The menstrual cycle is affected by the follicles' response to ovulation inhibitors. In both mice and monkeys, progesterone plays a key role in the initiation of pregnancy and gestation.

Unverified Answer

Have there been any new discoveries for treating abnormalities, drug-induced?

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In our survey there was no new drug to treat adrenal masses and no new medications for treatment of drug-induced abnormalities. Abnormalities that can be treated with therapy are adrenal tumors that have either [secreting tumors] or [nonsecreting] and [adenomas] and [adenocarcinomas] tumors that are nonsecretory.

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What is the primary cause of abnormalities, drug-induced?

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The primary cause of abnormal findings may change over time. A correct understanding of the normal anatomy and physiology, in addition to the correct performance of the test, is critical in proper management.

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