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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: Completed Phase 1 study of Contraception, sponsored by Sun Pharmaceutical Industries Limited.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessment of mean trough levels of medroxyprogesterone acetate (MPA) on Day 1, Day 29, Day 57 and Day 85
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 |
What the finished NCT01699022 record still lists
NCT01699022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 454-participant average among 72 other Contraception trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01699022's enrollment target sits among peer trials
17 65th of 72 higher than 7 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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