NCT06067217

Brief Summary

Abnormal uterine bleeding is the most common problems to discontinue Depo-medroxyprogesterone acetate (DMPA) in Thailand. This clinical trial use to provide drug to stop abnormal uterine bleeding from DMPA

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

September 13, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

November 18, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

September 13, 2023

Last Update Submit

November 14, 2023

Conditions

Abnormal Uterine BleedingTranexamic AcidEstrogenDepot Medroxyprogesterone Acetate

Keywords

AUBDMPATranexamic acidEstrogen

Outcome Measures

Primary Outcomes (1)

  • Day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen

    To Compare day to stop abnormal uterine bleeding between groups after receiving Tranexamic acid and estrogen

    1 week after intervention

Secondary Outcomes (3)

  • Side effect after receiving Tranexamic acid

    1 week after intervention

  • Side effect after receiving estrogen

    1 week after intervention

  • Frequency of bleeding after DMPA injection

    after DMPA injection

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

Tranexamic acid 250 mg oral three times/day

Drug: Tranexamic acid 250 mg oral tablet

Progynova

EXPERIMENTAL

Progynova 1 mg oral three times/day

Drug: Progynova 1 mg oral tablet

Interventions

Tranexamic acid 250 mg oral tabletDRUG

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Tranexamic acid
Progynova 1 mg oral tabletDRUG

Compare between tranexamic acid and progynova to stop abnormal uterine bleeding in DMPA users

Progynova

Eligibility Criteria

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

You may qualify if:

  • Abnormal uterine bleeding more than 7 days after first DMPA injection
  • Provide inform consent with patient
  • Can understand thai language

You may not qualify if:

  • Have contraindication to use Tranexamic acid and estrogen such as hypertension, Stroke, MI, DM, Renal disease, Liver disease, CA breast etc.
  • Have pathology in uterus from pelvic examination, pap smear and ultrasound
  • Current pelvic infection
  • Postpartum less than 6 months
  • History deep vein thrombosis
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Krittiporn Mahachiraphat

Bangkok, Ratchathewi, 10400, Thailand

RECRUITING

Krittiporn Mahachiraphat, M.D.

Phaya Thai, Ratchathewi, 10400, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Metrorrhagia

Interventions

Tranexamic AcidTabletsEstradiol

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsDosage FormsPharmaceutical PreparationsEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Krittiporn Mahachiraphat, M.D.

CONTACT

0877996647qqq_ruttew@live.com

Sitanan Lertsiripanich, M.D.

CONTACT

0829727222sitanan.lert@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Drug in concealed envelop which participant and care provider aren't see
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

October 4, 2023

Study Start

September 30, 2023

Primary Completion

August 1, 2024

Study Completion

August 30, 2024

Last Updated

November 18, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)