NCT03994432

Brief Summary

The main aim of this study is to evaluate whether a dietary recommendation based on the Mediterranean diet's principles associated with a regular aerobic physical activity, according to the "7 minutes workout", may improve pain symptoms in patients with symptomatic endometriosis (pelvic pain with numerical rating scale, NRS ≥ 4), in therapy with estrogen-progestins or progestins.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2023

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

March 25, 2019

Last Update Submit

July 4, 2025

Conditions

Endometriosis

Keywords

mediterranean dietendometriosisphysical activity7 minutes work-out

Outcome Measures

Primary Outcomes (1)

  • Pelvic pain changes in patients with endometriosis who follow a mediterranean diet and a regular physical activity

    The presence and severity of dysmenorrhea, deep dyspareunia, and non-menstrual pelvic pain will be assessed using an 11-point numeric rating scale (NRS), with 0 indicating absence of pain and 10 pain as bad as it could be. Scores 1 to 4 will be considered mild pain, 5 to 7 moderate pain, and 8 to 10 severe pain. Patients will be considered for enrollment if they complained of at least moderate or severe pelvic pain (NRS score ≥ 4).

    12 months

Secondary Outcomes (5)

  • The degree of satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity

    12 months

  • Changes in state of anxiety and depression in patients with endometriosis who follow a mediterranean diet and a regular physical activity

    12 months

  • Changes in sexual dysfunction and sexual satisfaction in patients with endometriosis who follow a mediterranean diet and a regular physical activity

    12 months

  • Changes in quality of life in patients with endometriosis who follow a mediterranean diet and a regular physical activity.

    12 months

  • Changes in global improvement over time in patients with endometriosis who follow a mediterranean diet and a regular physical activity.

    12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

patients with symptomatic endometriosis in therapy with estro-progestins or progestins, who will be asked to follow a mediterranean diet and to practice an aerobic physical exercise according to the "7-minutes workout" model

Behavioral: intervention group

Control group

NO INTERVENTION

patients with symptomatic endometriosis in therapy with estro-progestins or progestins.

Interventions

intervention groupBEHAVIORAL

follow a mediterranean diet and practice a regular aerobic exercise according to the "7-minutes workout" model.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 45 years
  • body mass index between 18 and 29.9
  • women with symptomatic endometriosis (pelvic pain with NRS score ≥ 4), in therapy with estro-progestins or progestins
  • not seeking conception

You may not qualify if:

  • associated diseases that cause pelvic pain regardless of the presence of endometriosis, or chronic intestinal diseases (Crohn's disease or ulcerative rectocolitis).
  • patients in note for all kind of surgery
  • women who conduct a strong physical activity.
  • women who follow vegetarian-vegan diet regimens.
  • metabolic diseases that require specific dietary indications (diabetes and celiac disease, food allergies).
  • medical contraindications to proposed physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laura Buggio Centro Endometriosi e Metrorragie Clinica Mangiagalli, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

EndometriosisMotor Activity

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

June 21, 2019

Study Start

January 10, 2019

Primary Completion

July 20, 2020

Study Completion

November 20, 2023

Last Updated

July 9, 2025

Record last verified: 2025-06

Locations

IT(1)