Adenomyosis Clinical Trials

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PAIN-GP: Project Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Despite recent increases in both medical and recreational cannabis use in the United States and globally, little research has been conducted to determine the potential applications for womens health. A variety of medical cannabis and hemp-derived products on the marketplace claim to hold efficacy for many womens health-related conditions, including gynecologic pain. This 7-day study of individuals living with endometriosis, adenomyosis, or chronic pelvic inflammatory disease (PID), will identify specific targets and mechanisms underlying the potential impact of a hemp-derived, full-spectrum, high-CBD product in individuals with gynecologic pain.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Healthy Volunteers: f
View:

• Provides informed consent

• Sex assigned female at birth

• Capable of having menstrual cycles

• Aged 21+

• Endorses one of the following gynecologic pain conditions: endometriosis, adenomyosis, chronic pelvic inflammatory disease (PID)

• Stable medication/psychotherapy regimens for at least 3 months prior to starting the study, including hormonal contraceptives

⁃ Additional inclusion criteria for those in the PK subgroup:

• Willingness to participate in the PK procedures (i.e., agree to an indwelling catheter with repeated blood collection)

Locations
United States
Massachusetts
McLean Hospital
RECRUITING
Belmont
Contact Information
Primary
Staci Gruber, PhD
gruber@mclean.harvard.edu
617-855-2762
Backup
Rosie Smith, M.S.
rsmith@mclean.harvard.edu
617-855-2908
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2029-01
Participants
Target number of participants: 60
Treatments
Experimental: CBD study product: 1mL dose
Participants in this arm will take 1mL of the CBD study product three times per day
Experimental: CBD study product: 0.5mL dose
Participants in this arm will take 0.5mL of the CBD study product three times per day
Placebo_comparator: Placebo
Participants in this arm will take the placebo study product three times per day
Sponsors
Leads: Staci Gruber, Ph.D.
Collaborators: National Center for Complementary and Integrative Health (NCCIH)

This content was sourced from clinicaltrials.gov