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A Randomized Open-Label Trial Comparing GnRH Antagonist Monotherapy versus Add-Back Therapy(GnRH Antagonist with estrogen+progesterone)in Women with Uterine Fibroids and Abnormal Uterine Bleeding: Evaluation of Clinical and Bone Health Outcomes

GNRH Antagonist monotherapy vs Add-back therapy in Abnormal Uterine Bleeding with Leiomyoma(AUB-L)- An open label randomized control trial assessing clinical and skeletal outcomes - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101789
Enrollment
136
Registered
2026-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified

Interventions

Intervention1: GNRH Antagonist (150mg OD) per orally: Treatment of AUB-L Intervention2: GNRH Antagonist(150mg) + Estrogen(1mg) and Progesterone(0.5mg) per orally: Treatment of AUB-L Control Interventi

Sponsors

Dr Shalini Shukla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All reproductive age women 18-50 years with symptomatic abnormal uterine bleed associated with leiomyoma

Exclusion criteria

Exclusion criteria: 1-Known case of osteoporosis 2-Contraindications to hormonal therapy 3-Previous surgical treatment of fibroids 4-Pregnancy,lactation or plans for conception 5-Known case of depression or mood disorders 6-Patients with hepatic impairment

Design outcomes

Primary

MeasureTime frame
1.To compare efficacy of GNRH antagonist monotherapy vs add back therapy in reducing heavy menstrual flow associated with AUB-L, baseline values and at 3 and 6 months. 2.To evaluate change in BMD due to GNRH antagonist alone vs add back therapy at baseline and at 6 months.Timepoint: 1.To compare efficacy of GNRH antagonist monotherapy vs add back therapy in reducing heavy menstrual flow assosciated with AUB-L at baseline and at 3 and 6 months. 2.To evaluate change in BMD due to GNRH antagonist alone vs add back therapy at baseline and at 6 months.—

Secondary

MeasureTime frame
To compare side common side effects across across the 2 study arms.Timepoint: Lipid profiles & LFT 6 weekly.—

Countries

India

Contacts

Public ContactDr Shalini Shukla

AIIMS DEOGHAR

shalinishukla839@gmail.com8967421676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026