NCT05985980

The Effects of Menstrual Cycle Phase on Exercise Treadmill Test Results in Premenopausal Women

Completed Results posted Last updated 15 April 2026

What this trial tests

trial testing Exercise Treadmill Test (ETT) in Menstrual Cycle in 47 participants. Completed in 12 September 2023.

Timeline

1 March 2023

Primary endpoint
11 September 2023

12 September 2023

Quick facts

Lead sponsor	Istanbul Medeniyet University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	47
Start date	1 March 2023
Primary completion	11 September 2023
Estimated completion	12 September 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Exercise Treadmill Test (ETT)

Conditions studied

• Menstrual Cycle — all drugs for Menstrual Cycle →
• Exercise Treadmill — all drugs for Exercise Treadmill →

Sponsor

Istanbul Medeniyet University

Who can join

Adults 20 to 55, female only, with Menstrual Cycle or Exercise Treadmill. 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.

ST/HR Index (μV/Bpm) Primary · approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

The ST/HR index (μV/bpm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System at the end of the exercise treadmill test (ETT).

Group	Value	95% CI
Early Follicular Phase	1.2	± 0.82
Late Follicular Phase ETT	1.3	± 0.59

High-sensitive Cardiac Troponin T (ng/L) After ETT Secondary · approximately 1 hour each during the exercise treadmill tests performed at the early and late follicular phase of the menstrual cycle

High-sensitive cardiac troponin T levels (hs-cTnT) are measured by Roche kit before and after the exercise treadmill test both at the early and late follicular phases of the menstrual cycle.

Hs-cTnT before ETT

Group	Value	95% CI
Hs-cTnT Before and After ETT at the Early Follicular Phase	3.3	± 1.1
Hs-cTnT Before and After ETT at the Late Follicular Phase	3.6	± 1.4

Hs-cTnT after ETT

Group	Value	95% CI
Hs-cTnT Before and After ETT at the Early Follicular Phase	3.6	± 1.4
Hs-cTnT Before and After ETT at the Late Follicular Phase	3.6	± 2.5

Maximal Exercise Capacity (METs Score) Secondary · approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

The maximal exercise capacity (METs score) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System at the end of the exercise treadmill test (ETT).

Group	Value	95% CI
Early Follicular Phase	10.0	± 1.9
Late Follicular Phase ETT	10.5	± 1.2

ST/HR Slope (μV/Bpm) Secondary · approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

ST/HR slope (μV/bpm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System at the end of the exercise treadmill test (ETT).

Group	Value	95% CI
Early Follicular Phase	1.8	± 1.2
Late Follicular Phase ETT	1.7	± 0.5

Maximal Horizontal or Down Slope ST Segment Depression (mm) During Exercise Treadmill Test Secondary · approximately 15 minutes each during the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

Maximal horizontal or down slope ST segment depression (mm) is automatically generated by the General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System at the end of the exercise treadmill test (ETT).

Group	Value	95% CI
Early Follicular Phase	0.13	± 0.08
Late Follicular Phase ETT	0.15	± 0.08

Estrogen Levels Before the Exercise Treadmill Test. Secondary · approximately 1 hour before the exercise treadmill tests performed at the early and late follicular phases of the menstrual cycle

Estrogen levels are measured 1 hour before the exercise treadmill test (ETT) at the early and late follicular phases of the menstrual cycle.

Group	Value	95% CI
Estrogen Before the ETT at the Early Follicular Phase	33.3	22.3 – 63.3
Estrogen Before the ETT at the Late Follicular Phase	105.0	64.7 – 209.0

Sponsor's own description

False positive results are commonly observed in women after exercise treadmill test (ETT). The effects of menstrual cycle on the results of ETT in premenopausal women have not been clearly defined. Primary purpose of the study is to investigate the biological causes of false positive test results in the ETT in premenopausal women. Estrogen is known to have direct vasodilatory effects on coronary arteries. The early and late follicular phases of the menstrual cycle are characterized by low and high estrogen levels, respectively. The early follicular phase starts on the first day of the menstrual cycle and ends when estrogen begins to increase. It is characterised by increasing luteinizing hormone (LH) and follicle stimulating hormone (FSH) and low estrogen levels. The estrogen levels increase several folds in the late follicular phase. The hypothesis of the study is that ETT results will change at the early and late follicular phases of the menstrual cycle in premenstrual women. Premenopausal women between the ages of 20-55 years, who apply to the cardiology outpatient clinics of Göztepe City Hospital with chest pain. Patients who are ordered to have an ETT will be included in the study. ETT will be performed separately during the early and late follicular phases of the menstrual cycle.

The major finding of Exercise Treadmill Test is the ST segment deviation from the baseline. The ST segments are evaluated 60-80 ms after the J point. ECG positive Exercise Treadmill Test result was defined as ≥ 1 mm (0.1 mV) horizontal or downsloping ST depression in at least 3 consecutive beats.

Chest pain or inadequate hemodynamic response during Exercise Treadmill Tests are considered clinically positive Exercise Treadmill Test result. Tests that do not meet these criteria but show ST segment changes or had low diagnostic value due to baseline ECG changes are considered indeterminate Exercise Treadmill Test results.

Automated measurements and mathematical calculations are recorded in the Exercise Treadmill Test system (General Electronic GE Healthcare T2100-ST Treadmill \& CASE 6.73 Stress Test System). ST/HR index during Exercise Treadmill Tests at the early and late follicular phases of the menstrual cycle (µV/beats per minute (bpm)) will be compared in all patients. The secondary endpoints were ST/HR slope, maximum ST segment depression (mm), maximum exercise capacity, and the change in estrogen levels between the early and late follicular phases of the menstrual cycle. The study will also compare the concentrations of hs-cTnT before and after Exercise Treadmill Test. Exercise Treadmill Test results are evaluated by 2 different cardiologists and categorized as positive/indeterminate/negative Exercise Treadmill Test results. The concentrations of Hs-cTn are measured before and 15 minutes after Exercise Treadmill Test.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Menstrual Cycle on Exercise Treadmill Parameters and Cardiac Troponin Release in Premenstrual Women.
   Oktay A, Torustag I, Isman FK, Agirbasli M. · · 2025 · PMID 40564868 · DOI 10.3390/diagnostics15121548