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NCT01699022 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
A Phase 1 study of Contraception, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01699022 is a Phase 1 study of Contraception that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 17 participants, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01699022, a Phase 1 study of Contraception, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The current study will assess the steady-state pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate (MPA) and estradiol (E2) after administration of Cyclofem® and will provide critical information to determine similar bioavailability of Cyclofem to Lunelle in women residing in the United States of America.
Conditions Studied
Interventions
- DRUG Injection Cyclofem
Study Locations (1)
Virginia
- Clinical Research Center Norfolk, Virginia 601 Colley Avenue, - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01699022
The ClinicalTrials.gov registry entry for NCT01699022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (96% lower). The listed sponsor is Sun Pharmaceutical Industries Limited, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Injection Cyclofem is the first listed.
NCT01699022 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT01699022 about?
NCT01699022 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Study of Cyclofem". Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The current study will assess the steady-state pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate (MPA) and...
What is the current status of trial NCT01699022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-06. Estimated completion is 2011-12.
What conditions does trial NCT01699022 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT01699022?
The interventions under investigation include: Injection Cyclofem (DRUG).
Who is sponsoring clinical trial NCT01699022?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01699022 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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