Breakthrough bleeding Urological and Genital Diseases Abnormal vaginal bleeding
Conditions
Interventions
Administration of CDB-2914 for three consecutive days, for the first three months after LNG-IUS insertion.
Sponsors
National Institute of Child Health and Development (NICHD) (USA)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy female volunteers aged between 19 to 48 years 2. Requesting and receiving a LevoNorGestrel IntraUterine System (LNG-IUS) for contraception 3. Must have menstrual cycle of 17 to 42 days, lasting not longer than ten days 4. Not currently using any form of hormonal treatment
Exclusion criteria
Exclusion criteria: 1. Is less than three months postpartum 2. Is less than one month post-lactation 3. Has been sterilised 4. Abnormal laboratory test finding clinically significant at screening or insertion 5. Currently participating in another study 6. History of cancer in the five years previously 7. History of significant medical disease 8. History of significant psychatric illness 9. Is currently on corticosteroid therapy 10. Unwilling or unsuitable for assessment and follow up 11. History of drug/alcohol abuse in past year 12. Found to have significant gynaecological disorder 13. History of abnormal vaginal bleeding 14. Has coagulopathy or on anticoagulation 15. Allergy to ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Suppression of breakthrough bleeding in new users of LNG-IUS users. 2. Acceptability of breakthrough bleeding frequency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Underlying mechanism of breakthrough bleeding. | — |
Countries
United Kingdom
Outcome results
None listed