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To study the effectiveness of combined oral contraceptives versus tranexamic acid in abnormal uterine bleeding - ovulatory dysfunction.

Comparative study of effectiveness of combined oral contraceptives versus tranexamic acid in abnormal uterine bleeding - ovulatory dysfunction (AUB-O)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/052122
Enrollment
100
Registered
2023-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N921- Excessive and frequent menstruation with irregular cycle

Interventions

Intervention1: COMBINED HORMONAL ORAL CONTRACEPTIVE PILLS: REDUCTION IN MENSTRUAL BLOOD LOSS IN PATIENTS WITH AUB-O USING COMBINED HORMONAL ORAL CONTRACEPTIVE PILLS DOSE: ETHINYL ESTRADIOL 30 MCG + L

Sponsors

GMERS HOSPITAL, GOTRI, VADODARA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.MENSTRUATING FEMALES WITH HEAVY MENSTRUAL BLEEDING PRESENTING TO OPD. 2.THE DIAGNOSIS OF OVULATORY DYSFUNCTION LEADING TO AUB WITH THE HELP OF CLINICAL EXAMINATION AND PELVIC ULTRASOUND. 3.NORMAL TSH LEVEL.

Exclusion criteria

Exclusion criteria: 1.PRESENCE OF OTHER CAUSES OF AUB. 2.PRESENCE OF PREGNANCY. 3.PRESENCE OF A DIAGNOSED BLEEDING DISORDER. 4.INTAKE OF MEDICATIONS THAT INCREASES THE RISK OF BLEEDING OR THAT CAN INTERFERE WITH THE ACTION OF ORAL CONTRACEPTIVE PILLS. 5.POSTMENOPAUSAL BLEEDING. 6.PRESENCE OF HISTORY OF THROMBOEMBOLIC DISEASE OR STROKE. 7.PRSENCE OF HISTORY OF SMOKING.

Design outcomes

Primary

MeasureTime frame
To determine the effectiveness of Combined hormonal oral contraceptive pills compared with tranexamic acid in the treatment of AUB-O. Outcome will be measured in terms of treatment success and reduction in menstrual blood loss by amount and duration with the help of pictorial blood loss assessment chart (PBAC) at the completion of period of 3 months.Timepoint: Assessment done at baseline and at end of 3 months—

Secondary

MeasureTime frame
To determine the improvement in the mean hemoglobin levels after treatment with combined hormonal oral contraceptive pills compared with tranexamic acid at the completion of period of 3 months.Timepoint: Improvement in hemoglobin levels from baseline to the end of 3 months.—

Countries

India

Contacts

Public ContactDR KALYANI UDDHAV PANSARE

GMERS Medical College and Hospital, Gotri

drashishshah2001@yahoo.com8849450012

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026