NCT01699022 is a Phase 1/Phase 2 clinical trial of Injection Cyclofem in Contraception, sponsored by Sun Pharmaceutical Industries Limited.

Who is sponsoring NCT01699022?

NCT01699022 is sponsored by Sun Pharmaceutical Industries Limited.

What drugs are being tested in NCT01699022?

Interventions in NCT01699022: Injection Cyclofem.

What condition does NCT01699022 study?

NCT01699022 studies Contraception.

Is NCT01699022 still recruiting?

NCT01699022 is currently completed. Last updated 19 August 2020.

Are results published for NCT01699022?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-19 · How we verify

NCT01699022

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetic and Pharmacodynamic Study of Cyclofem

Completed Phase 1/Phase 2 Results posted Last updated 19 August 2020

What this trial tests

Phase 1/Phase 2 trial testing Injection Cyclofem in Contraception in 17 participants. Completed in 1 December 2011.

Timeline

1 June 2010

Primary endpoint
1 July 2011

1 December 2011

Quick facts

Lead sponsor	Sun Pharmaceutical Industries Limited
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	17
Start date	1 June 2010
Primary completion	1 July 2011
Estimated completion	1 December 2011
Sites	1 location across United States

Drugs / interventions tested

Injection Cyclofem

Conditions studied

Contraception — all drugs for Contraception →

Sponsor

Sun Pharmaceutical Industries Limited — full company profile →

Who can join

Adults 18 to 45, female only, with Contraception. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Medroxyprogesterone Acetate (MPA) Concentrations
Time frame: "Day 1", "Day 29", "Day 57' and 'Day 85"
Assessment of mean trough levels of medroxyprogesterone acetate (MPA) on Day 1, Day 29, Day 57 and Day 85
Medroxyprogesterone Acetate (MPA) Pharmacokinetics
Time frame: "Day 85"
The mean serum concentration-time profile for medroxyprogesterone acetate (MPA) after three consecutive monthly intramuscular administration of Cyclofem (AUC). Peripheral blood sample for MPA was to be drawn three times a week for PK assessment during the third treatment month (Days 58, 60, 62, 64, 67, 69, 71, 75, 78, and 85) and for Day 85 (28 days post 3rd dose).
Medroxyprogesterone Acetate (MPA) Pharmacokinetics Cmax
Time frame: 85 days
The mean serum concentration-time profile for medroxyprogesterone acetate (MPA) after three consecutive monthly intramuscular administration of Cyclofem
Medroxyprogesterone Acetate (MPA) Pharmacokinetics Tmax
Time frame: "Day 85"
Mean serum medroxyprogesterone acetate (MPA) concentrations peaked at 4.1 days (range 1 - 21 days) after the third monthly administration of Cyclofem.
Medroxyprogesterone Acetate (MPA) Pharmacokinetics T1/2
Time frame: "Day 85"
Estradiol (E2) Concentrations
Time frame: "Day 1", "Day 29", "Day 57' and ''Day 85"
Mean serum estradiol (E2) concentrations on Day 1, Day 29, Day 57 and Day 85

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Contraception

Currently open trials in the same condition.

NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting

Other Sun Pharmaceutical Industries Limited trials

Trials by the same sponsor.

NCT06415279 — A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients · Phase 4 · completed
NCT06415292 — A Study to Evaluate the Impact of Clascoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients · Phase 4 · completed
NCT06336603 — A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne · Phase 4 · completed
NCT06336629 — A Study Assessing the Efficacy and Safety of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clinda · Phase 4 · completed
NCT06415305 — A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01699022 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sun Pharmaceutical Industries Limited
Last refreshed: 19 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01699022.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing