Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles
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|ClinicalTrials.gov Identifier: NCT02269241|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2014
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: LF111 (drospirenone)||Phase 3|
This trial is a prospective, multicenter, open-label, non-controlled trial in female subjects, including adolescents between the ages of 15+(inclusive) who present to the clinic seeking contraception, who are postmenarcheal and premenopausal.
At screening, informed consent will be obtained and the screening procedures will be performed. After confirmation of the subject's eligibility, the subject will be provided with the investigational product and trained in the use of an electronic diary. Afterwards, the subjects will attend visit the clinical site on Day 20±2 of the 1st, 3rd, 6th and 9th cycles and on Day 29+2 of the 13th cycle. The last clinical site visit will occur 10-14 days after the 13th cycle visit.
The trial will include women who have never used hormonal contraceptives before consent (naïve users), women who have not used hormonal contraceptives in the past three months before consent or who have used hormonal contraceptives in the past but have a contraceptive-free time of less than three months before consent (previous users) as well as women directly switching from another hormonal method (switchers). Women who have used hormonal contraceptives in the past but have a contraceptive-free time of less than three months before consent are allowed to be included into the trial if they had at least one complete menstrual cycle before enrollment.
A population pharmacokinetic (PK) analysis planned in the whole subject population, will obtain sparse blood samples to determine plasma concentrations. In total, four blood samples will be collected: two samples each will be collected during the 1st cycle and during the 6th cycle of treatment.
Adverse events and safety information will be collected throughout the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1045 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pivotal, Multicenter, Non-Comparative Trial on the Contraceptive Efficacy, Safety, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||October 5, 2017|
|Estimated Study Completion Date :||March 15, 2018|
Experimental: LF111 (drospirenone)
single treatment arm receives LF111
Drug: LF111 (drospirenone)
One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
Other Name: CF111
- Number of pregnancies (after correction) [ Time Frame: up to 13 months ]Number of pregnancies occurring after correction for back-up contraception and sexual activity
- Number of pregnancies (all) [ Time Frame: up to 13 months ]All pregnancies which occur during the trial
- Number of pregnancies (method failures) [ Time Frame: up to 13 months ]Number of pregnancies that occurred due to women who used the product incorrectly
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: up to to 13 months ]Adverse events and changes in vital signs, clinical laboratory parameters, vaginal bleeding patterns
- Drospirenone plasma concentration [ Time Frame: at 6 months ]
- Drospirenone area under the curve [ Time Frame: at 6 months ]
- Drospirenone volume of distribution [ Time Frame: at 6 months ]
- Drospirenone apparent clearance [ Time Frame: at 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269241
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|Study Director:||William Bryant, III||Exeltis USA, Inc.|