NCT04938622: BioE

Bioenergetics of Exercise-Induced Menstrual Disturbances

Completed NA Last updated 24 June 2021

What this trial tests

NA trial testing Sedentary Control in Menstruation Disturbances in 47 participants. Completed in 30 April 2005.

Timeline

1 May 2001

Primary endpoint
30 April 2005

30 April 2005

Quick facts

Lead sponsor	Penn State University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	47
Start date	1 May 2001
Primary completion	30 April 2005
Estimated completion	30 April 2005

Drugs / interventions tested

• Sedentary Control
• Exercising control
• 15 percent energy deficit
• 30 percent energy deficit
• 30 percent energy deficit (15/15)
• 60 percent energy deficit

Conditions studied

• Menstruation Disturbances — all drugs for Menstruation Disturbances →
• Luteal Phase Defect — all drugs for Luteal Phase Defect →
• Amenorrhea — all drugs for Amenorrhea →
• Oligomenorrhea — all drugs for Oligomenorrhea →

Sponsor

Penn State University

Who can join

Adults 18 to 30, female only, with Menstruation Disturbances or Luteal Phase Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Menstrual disturbances are frequently observed in physically active women and female athletes. Short term prospective studies have shown that diet and exercise interventions can lead to decreases in Luteinizing hormone (LH) pulsatility, however these studies are unable to capture further changes in menstrual status. One longer term prospective study over two menstrual cycles showed that weight loss elicited menstrual disturbances, but there were no quantifiable measurements of energy availability. Thus, the primary purpose of this study was to assess how varying levels of energy deficiency created through a combination of caloric restriction and exercise affect menstrual function in young, premenopausal, sedentary women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.