Menstrual IrregularitiesPhase 1/2NCT07319286
Role of Glucagon-like Peptide-1 Receptor Agonists in Menstrual Irregularities in Adolescent Females With Type 1 Diabetes Mellitus
A Phase 1/2 study testing Dulaglutide in people with Menstrual Irregularities and Type1 Diabetes Mellitus, run by Ain Shams University at 2 sites in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Menstrual Irregularities, Type1 Diabetes Mellitus, Glucagon-Like Peptide-1 Receptor Agonists
- What is being tested?
- Dulaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 4 Aug 2025to Mar 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Type 1 Diabetes Mellitus according to ISPAD criteria
- Use of continuous glucose monitoring (CGM)
- Receiving regular insulin therapy
- Regular follow-up at a diabetes clinic
- Female participants aged 12 to 18 years
- At least 2 years post-menarche
- Poor glycemic control, defined as HbA1c ≥ 7%
Who cannot join
- Presence of medical conditions known to cause menstrual irregularities, including:(Connective tissue disorders, Autoimmune diseases, Clinical thyroid dysfunction, Neurological diseases).
- History of severe hypoglycemia within the past 12 months
- Other causes of abnormal uterine bleeding, including:(Structural causes (e.g., leiomyoma, endometrial polyp), Coagulation disorders, Ovulatory disorders (e.g., hyperprolactinemia, hyperandrogenism), Iatrogenic causes (e.g., steroid therapy, oral contraceptive use)
- Family history of medullary thyroid carcinoma or multiple endocrine neoplasia History of pancreatitis
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Ain shams university
Cairo, Cairo Governorate, 00202
Ain shams university
Cairo, Cairo Governorate, 11517
About this study
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 .
Read the 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
- Being tested
- Dulaglutide
- Keywords
- Adolescent Health, Female Reproductive Health
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | 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: this group will only receive conventional insulin therapy. |
| dulaglutide GROUP | Active comparator | 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. Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Self-Reported Menstrual Irregularities
Number and percentage of participants reporting menstrual irregularities (including oligomenorrhea, amenorrhea, or irregular menstrual cycle length) based on participant self-report.
Measured: Baseline
Secondary outcomes (1)
Frequency of Self-Reported Menstrual Irregularities
Change from baseline in the number and percentage of participants reporting menstrual irregularities following 3 months of treatment
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start4 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual IrregularitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randa m. Matter, MD, Study director, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319286
- Sponsor's protocol ID
- FMASU MD142/2025
- Status last verified
- Oct 2025
- First submitted
- 5 Dec 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the primary research team.
Publications
Almohareb SN, Alfayez OM, Aljuaid SS, Alshahrani WA, Bakhsh G, Alshammari MK, Al Yami MS, Alshaya OA, Alomran AS, Korayem GB, Almohammed OA. Effectiveness and Safety of GLP-1 Receptor Agonists in Patients with Type 1 Diabetes. J Clin Med. 2024 Oct 30;13(21):6532. doi: 10.3390/jcm13216532.
PubMed 39518671