Contraception Clinical Trial
Official title:
Prospective, Non-interventional, 2-year Post-authorization Safety Study for QLAIRA®
Qlaira is a combined oral contraceptive (COC) containing dienogest/estradiol valerate being
the first oral contraceptive delivering estradiol. It has been recently approved in Mexico.
To evaluate the clinical profile of this drug combination under routine medical condition, a
post-authorization safety study required by Mexican Health Authorities will be conducted in
Mexican women.
The study will be performed as a descriptive study, no hypothesis will be tested. The cohort
consists of 300 new users (first-ever users or switchers) of Qlaira under routine medical
conditions. Subjects should provide all necessary information on health-related events or
changes in health status during Qlaira use.
Primary variable will be the incidence of Adverse Events (AE) at any time point, whether or
not related to Qlaira during at least 2 years of observation.
In order to comply with the criteria of a non-interventional study, women only will be
informed about the study, asked to participate and included in the study after Qlaira has
been prescribed.
Study patients follow-up will be done in accordance with common clinical practice as
described at Mexican Official Guidelines for prescription of Family Planning Methods (NOM
005-SSA2-1993).
n/a
| 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 |
NCT02456584 -
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods
|
Phase 1 | |
| Completed |
NCT02718222 -
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
|
N/A | |
| 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 |