Trial Condition(s):
Nulliparous
Scandinavian Mirena Insertion Nulliparous Trial.
Bayer Identifier:
14015
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.
Inclusion Criteria
- Nulliparous women Mirena insertion planned as contraceptive method
Exclusion Criteria
- Ongoing or suspected pregnancy; - Ongoing or recidivating genital infection; - Cervicitis; - Cervical dysplasia; - Malignancy in uterus or cervix; - Confirmed or suspected hormone sensitive neoplasia including breast cancer - Undiagnosed abnormal uterine bleeding; - Uterine anomaly including myoma if the cavity of the uterus is restricted; - Conditions that cause increased risk of infections; - Acute liver disease or liver tumour; - Allergy to the active substance or any component of the IUD
Trial Summary
Enrollment Goal
224
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Mirena (Levonorgestrel IUS, BAY86-5028)
Accepts Healthy Volunteers
Yes
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Sweden | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Scandinavian Mirena Insertion Nulliparous Trial of an observational study.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Evaluation of the insertion procedure of Mirena in nulliparous womenTimeframe: At the insertion time point
Secondary Outcome
- PainTimeframe: At the insertion time point
- Continuation rateTimeframe: 12-16 weeks post insertion
- Bleeding PatternTimeframe: 12-16 weeks post insertion
- SatisfactionTimeframe: 12-16 weeks post insertion
Additional Information
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