Contraception Clinical Trial
Official title:
An Open-Label, Single Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profiles and Metabolite Identification of [14C]-Estetrol in Healthy Female Volunteers
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
This will be an open-label, non-randomised, single dose study in healthy female volunteers of
non-child bearing potential.
Subjects will be screened for eligibility to participate in the study up to 28 days before
dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed
with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the
clinical unit on the morning prior to study drug administration (Day -1). Dosing will take
place on the morning of Day 1 after an overnight fast (approximately 10 h).
Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood,
urine and faeces samples will be collected. It is planned that subjects will be released as a
group when all subjects have achieved a mass balance cumulative recovery of >90% or if a mean
of <1% of the dose administered has been collected in urine and faeces within 2 separate,
consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces)
will be stopped and the subjects will undergo discharge assessments. If this criterion has
not been met by all subjects on Day 11, home collections of urine and faeces may be requested
at the discretion of the investigator for individual subjects.
;
| 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 |