Contraception Clinical Trial
Official title:
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties.
A large active post-marketing surveillance study has demonstrated that a 21-day regimen of
3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This
study investigates the risks of short and long-term use of a 24-day regimen of
drospirenone/ethinylestradiol in comparison to established OCs in a study population that is
representative of the actual users of the individual preparations.
INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms:
OCs containing drospirenone and OCs containing any other progestogen. The study was started
in the USA in April 2005 and was extended to several European countries in September 2008
based on the launch status of the 24-day regimen. New users of an OC (starters, switchers
without a pill intake break and recurrent users with a pill intake break [same or different
OC]) are accrued by a network of prescribing physicians. Baseline and follow-up information
are collected via a self-administered questionnaire. Data analysis will be based on
life-table methods comparing the cohorts. All analyses will make allowance for confounding,
using methods that will include multivariate techniques such as Cox regression.
;
| 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 |