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A phase IV study on Today Sponge in Indian Women desiring contraception

A phase IV study to evaluate the safety of Today Sponge (Vaginal Contraceptive Sponge) in Indian Women desiring contraception - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/03/018050
Enrollment
100
Registered
2019-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

None listed

Sponsors

Virchow Biotech Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. At risk for pregnancy and desiring contraception 2. Having regular menstrual cycle (21-35 days) 3. At low risk for HIV or other sexually transmitted infection 4. Use the test product as their primary method of contraception 5. Keep a diary of coital activity, product use, and adverse events 6. Signed informed consent before any study procedure is initiated.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of any vaginal infection or any symptom of STDs at baseline 2. Known allergy or hypersensitivity to Nonoxynol-9 3. Menopause for more than one month 4. Lactating women 5. Vaginal bleeding with unknown reasons 6. Genitourinary system anomaly 7. Hysteroptosis II or severe cystocele 8. Moderate to severe erosion of cervix 9. Malignant reproductive system tumors

Design outcomes

Primary

MeasureTime frame
Incidence of adverse drug reactions, especially infection and irritation in women using Today SpongeTimepoint: 12 months—

Secondary

MeasureTime frame
1. Rate of pregnancies categorized into method failure or user failure or planned pregnancyTimepoint: One year—

Countries

India

Contacts

Public ContactDr Aditi Datta

Virchow Biotech Private Limited

hnandigala@gmail.com23119481

Outcome results

None listed

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