Contraception Clinical Trial
— BERTAOfficial title:
Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern
NCT number | NCT03493295 |
Other study ID # | 19704 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 25, 2018 |
Est. completion date | March 15, 2021 |
Verified date | October 2023 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this non-interventional study (NIS) is to assess, under real-life conditions, woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years old (y.o.)) Spanish population taking into account their parity status. Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.
Status | Completed |
Enrollment | 587 |
Est. completion date | March 15, 2021 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Women in childbearing age, between 18-30 years old. - Women who have chosen a LNG-IUS as contraceptive method, after been adequately counselled by the physician about all contraceptive possible options. - Women who have chosen a LNG-IUS mainly for contraceptive reasons, not due to heavy menstrual bleeding. - Women with no desire to conceive for at least within the next 12 months. - Women capable of reading and writing Exclusion Criteria: - Women whose main reason to use a LNG-IUS is not a contraceptive reason. - Women with contraindication for LNG-IUS. - Women with previous experience with a IUS. - Women who have been diagnosed with heavy menstrual bleeding. - Women with degenerative or other kind of diseases that could directly negatively impact their daily life. - Women who have undergone a hysterectomy or irreversible contraceptive method. - Women participating in a clinical trial. - Women with a mental illness and unable to make decisions and follow instructions. - Women with amenorrhea - Women with clinical history of severe dysmenorrhea - Women with concomitant medication that may lead changes in bleeding pattern (e.g. antiplatelets and/or anticoagulants) |
Country | Name | City | State |
---|---|---|---|
Spain | Many locations | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Spain,
Perello Capo J, Lopez Gonzalez G, Rius-Tarruella J, Calaf Alsina J. Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):461-472. doi: 10.1080/13625187.2022.2112562. Epub 2022 Sep 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS | Overall satisfaction with LNG-IUS at end of observation/final visit (i.e. after approximately 12 months or at premature discontinuation). 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling "very dissatisfied" / "very satisfied" | At approximately 12 months(end of observation/final visit) | |
Secondary | Percentage of women rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale of overall satisfaction with the menstrual bleeding profile with LNG-IUS | Overall satisfaction rate with LNG-IUS at end of observation/final visit. 5 point Likert scale of overall satisfaction with the menstrual bleeding pattern with LNG-IUS with end labelling "very dissatisfied" / "very satisfied". | At 4-12 weeks after insertion, At approximately 12 months(end of observation/final visit) | |
Secondary | 8 item user satisfaction questionnaire to assess the satisfaction with menstrual bleeding pattern with LNG-IUS | Overall satisfaction with the menstrual bleeding profile with LNG-IUS at end of observation/final visit. | At approximately 12 months(end of observation/final visit) | |
Secondary | Spearman's correlation between overall satisfaction with LNG-IUS and overall satisfaction with menstrual bleeding pattern | At approximately 12 months(end of observation/final visit) | ||
Secondary | Percentage of subjects rating 1 (very dissatisfied) to 5 (very satisfied) in the 5-point Likert scale overall satisfaction with LNG-IUS | Overall satisfaction with LNG-IUS 4-12 weeks after insertion. 5 point Likert scale of overall satisfaction with LNG-IUS with end labelling "very dissatisfied" / "very satisfied" | At 4-12 weeks after insertion | |
Secondary | Overall satisfaction with the menstrual bleeding profile 4-12 weeks after insertion. | At 4-12 weeks after insertion | ||
Secondary | Ease of LNG-IUS insertion will be measured by investigator on an ordinal scale of "easy", "slightly difficult", "very difficult" | Ease of LNG-IUS insertion assessed by the investigator. | At initial visit (Day 0_LNG-IUS insertion) | |
Secondary | Pain at LNG-IUS insertion will be assessed by the clinician asking to the user on a ordinal scale of "none", "mild", "moderate" or "severe" | Pain at LNG-IUS insertion assessed by the user. | At initial visit (Day 0_LNG-IUS insertion) | |
Secondary | Percentage of women that would recommend a LNG-IUS to peers | Response in recommendation to peers item at final visit. | At approximately 12 months | |
Secondary | Reasons for change to/ choice a LNG-IUS assessed by a multiple choice item | At initial visit (Day 0_LNG-IUS insertion) | ||
Secondary | Descriptive analysis of demographic data | Women's profile defined by their sociodemographic and gynaecological characteristics. | At initial visit (Day 0_LNG-IUS insertion) | |
Secondary | Reasons for withdrawal | Up to approximately 12 months | ||
Secondary | Percentage of withdrawal | Up to approximately 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02577601 -
Impact of Combined Hormonal Contraceptives on UPA
|
Phase 4 | |
Completed |
NCT03153644 -
Improving Contraceptive Care for Women With Medical Conditions
|
||
Completed |
NCT04112095 -
Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use
|
Phase 3 | |
Recruiting |
NCT05521646 -
Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative
|
N/A | |
Active, not recruiting |
NCT04291001 -
Ovarian Function With ENG Implant and UPA Use
|
Early Phase 1 | |
Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
Completed |
NCT03438682 -
Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
|
||
Active, not recruiting |
NCT01948882 -
Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
|
N/A | |
Enrolling by invitation |
NCT04997499 -
Adolescent Subcutaneous (SQ) Injection Video Validation
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03154125 -
Sayana® Press Extension Study
|
Phase 3 | |
Withdrawn |
NCT03725358 -
A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.
|
N/A | |
Completed |
NCT02957630 -
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
|
Phase 1/Phase 2 | |
Completed |
NCT02718222 -
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
|
N/A | |
Completed |
NCT02456584 -
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
|
Phase 1 | |
Recruiting |
NCT02121067 -
LNG-IUS at 2 Weeks Postpartum
|
Phase 4 | |
Terminated |
NCT02169869 -
Immediate Postplacental IUD Insertion
|
N/A | |
Recruiting |
NCT02292056 -
Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions
|
N/A | |
Withdrawn |
NCT01930994 -
Kenya Sino-implant (II) PK Study
|
N/A |