CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Injection Cyclofemdrug
Likely dose
Injection Cyclofem 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01699022
NCT01699022Phase 2Completed
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Pharmacokinetic and Pharmacodynamic Study of Cyclofem

Sun Pharmaceutical Industries Limited·interventional·Posted Oct 3, 2012·Updated Sep 2, 2020

In Brief

A Phase 2 clinical trial evaluating Injection Cyclofem for Contraception. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsContraception
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2012
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.7 years ago

Interventions

Injection Cyclofemdrug

Injection Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials. Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection.