Trials / Enrolling By Invitation
Enrolling By InvitationNCT07319286
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
- Status
- Enrolling By Invitation
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Ain Shams University · Academic / Other
- Sex
- All
- Age
- 12 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to measure the frequency of menstrual irregularities among adolescent females with Type 1 diabetes mellitus and to assess the therapeutic effect of glucagon-like peptide-1 receptor agonist on menstrual irregularities in adolescent females with Type 1 diabetes mellitus .
Detailed description
All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: * Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. * Group 2: will only receive conventional insulin therapy. Dulaglutide is an FDA-approved drug in the U.S.; however, this study is conducted entirely outside the United States and is not under an FDA IND.
Conditions
- Menstrual Irregularities
- Type1 Diabetes Mellitus
- Glucagon-Like Peptide-1 Receptor Agonists
- Female Reproductive Health
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dulaglutide | All studied patients with T1DM with poor glycemic control will be screened for menstrual irregularities based upon detailed history Taking, those who were found to have menstrual irregularities will be subdivided into 2 groups: * Group 1: will receive additional dulaglutide at a dose escalating from o.75 to 1.5 mg /week for 12 weeks to the conventional insulin therapy. * Group 2: will only receive conventional insulin therapy. |
Timeline
- Start date
- 2025-08-04
- Primary completion
- 2026-04-01
- Completion
- 2026-08-01
- First posted
- 2026-01-06
- Last updated
- 2026-01-27
Locations
2 sites across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07319286. Inclusion in this directory is not an endorsement.