Commercial Weight Loss Program for Anovulation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anovulation+3 MoreCommercial Weight Loss Program - Behavioral
Eligibility
18 - 35
Female
What conditions do you have?
Select

Study Summary

This trial looks at the effects of weight loss on different aspects of health in obese women, specifically those with regular versus irregular menstrual cycles and/or PCOS.

Eligible Conditions
  • Anovulation
  • Weight Loss
  • Amenorrhea
  • Infertility

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: through study completion, an average of 13 months

Up to 7 months
Change from Baseline Ovulatory Function
Month 13
Change from Baseline Body Composition
Change from Baseline Menstrual Function
Change from Baseline Metabolic Status
Change from Baseline Ovarian Morphology
Change from Baseline Reproductive Hormones

Trial Safety

Trial Design

1 Treatment Group

Overweight Women
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Commercial Weight Loss Program · No Placebo Group · N/A

Overweight Women
Behavioral
Experimental Group · 1 Intervention: Commercial Weight Loss Program · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 13 months

Who is running the clinical trial?

Nutrisystem, Inc.Industry Sponsor
9 Previous Clinical Trials
678 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,827 Previous Clinical Trials
2,250,038 Total Patients Enrolled
2 Trials studying Anovulation
35 Patients Enrolled for Anovulation
Cornell UniversityLead Sponsor
150 Previous Clinical Trials
110,750 Total Patients Enrolled
Marla Lujan, PhDPrincipal InvestigatorCornell University

Eligibility Criteria

Age 18 - 35 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
If your BMI is ≥ 30 kg/m*, you are obese.
The survey asked women about their menstrual cycles, including whether they were regular, irregular, or had PCOS.
The person did not use hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment.