To study efficacy and safety of Progesterone SR tablets in patient with secondary amenorrhea

An Open label, Randomized, Multicentric, Parallel group, 4 arm, comparartive phase III study to evaluate the Efficacy and Safety of Progesterone SR oral tablets versus Progesterone oral tablets in women with secondary amenorrhea associated with normal estrogen levels.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/11/007433

Enrollment

388

Registered

2016-11-04

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Women with secondary amenorrhea associated with normal estrogen levels

Interventions

Intervention1: Progesterone 200mg SR tablets Progesterone 300mg SR tablets Progesterone 400mg SR tablets: 200 mg/300 mg/400 mg, orally Taken once a day at bed time 10 days a month Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Non hysterectomized women of the age of 25 to 45 years. 2.Women whose menstrual cycles disappear for 6 consecutive months with irregular menses or for 3 consecutive months with regular menses 3.Women willing to give informed consent

Exclusion criteria

Exclusion criteria: 1.Women with hypersensitivity to any of the test or control formulation drugs or their excipients 2.Pregnant or nursing women 3.Women of childbearing potential not using medically approved means of contraception 4.History of drug or alcohol abuse 5.Women who are in menopause phase 6.Women with undiagnosed irregular vaginal bleeding 7.Those with any medical condition judged by investigators to possibly jeopardize the evaluation of efficacy and safety of therapy will be excluded from the study 8.Women with malignancy (uterine breast) or with family history of malignancy 9.Women with gall stone disease 10.Women with DVT or history of CVD 11.Women with thyroid disease 12.Women with ovarian failure 13.Women with Ashermans Syndrome

Design outcomes

Primary

Measure	Time frame
1.Inducing withdrawal bleeding 2.maintaining regular bleeding, in women with secondary amenorrheaTimepoint: At day 0 At day 30 At day 60 At day 90	—

Secondary

Measure	Time frame
1.Tolerability 2.Changes in bleeding pattern post treatment as compared to baselineTimepoint: At day 0 At day 30 At day 60 At day 90	—

Countries

India

Contacts

Public ContactMr Sanjib Kumar Panda

Ocius Life Sciences Pvt Ltd

sanjib@ociuslife.com9003580729

Outcome results

None listed

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