Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

Contraception Clinical Trial

Official title:

Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456584
• Other study ID #: 702179
• Status: Completed
• Phase: Phase 1
• Start date: September 2015
• Est. completion date: August 30, 2018

Study information

• Verified date: October 2018
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Description:

This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Secondary study objectives are:

• To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart

• To evaluate the relationship between serum MPA concentration and suppression of ovulation

• To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

inclusion

Women may be included in the study if they meet all of the following criteria:

• in good general health

• age 18 to 40 years, inclusive

• willing to provide informed consent and follow all study requirements

• not pregnant

• does not desire to become pregnant in the next 24 months

• regular menstrual cycle (24 to 35 days)

• confirmed ovulation by serum P = 4.7 ng/mL in two consecutive samples during the pre-treatment phase of the study

• at low risk of pregnancy (e.g., sterilized, in exclusively same sex partnership, in monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD or condoms)

• has a body mass index of 18.0 to 35.0

• has hemoglobin =10.5 g/L

exclusion

Women will be excluded from participating in this study if they meet any of the following criteria:

• medical contraindications to DMPA use

• use of any of the following medications within 1 month prior to enrollment:

• any investigational drug

• prohibited drugs (per protocol)

• oral contraceptives

• LNG IUS or implant

• use of DMPA in the past 12 months

• use of a combined injectable contraceptive in the past 6 months

• recent pregnancy (within 3 months)

• current lactation

• ongoing or anticipated use of prohibited drugs (per protocol)

• known sensitivity to MPA

• plan to move to another location in the next 18 months

• any condition (social or medical) which in the opinion of the site investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• DMPA 150
injectable contraceptive
• DMPA 300
injectable contraceptive
• DMPA 104
injectable contraceptive

Locations

Country	Name	City	State
Dominican Republic	Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)	Santo Domingo
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
FHI 360	Asociación Dominicana Pro Bienestar de la Familia, Inc., Oregon Health and Science University

Countries where clinical trial is conducted

United States,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of time to ovulation		up to 18 months
Secondary	Cmax	Up to ovulation or 18 months following injection, whichever comes first	up to 18 months
Secondary	Aggregate of individual Cmax measurements and parameters		up to 18 months
Secondary	Type and frequency of adverse events		up to 18 months
Secondary	Blood pressure at follow up		up to 18 months
Secondary	Pulse at follow up		up to 18 months
Secondary	Weight at follow up		up to 18 months
Secondary	Measure of delayed return to ovulation		up to 18 months
Secondary	Serum concentrations of cortisol		7.5 months
Secondary	Number of participants with Injection site reactions		up to 18 months
Secondary	Product acceptability		up to 18 months
Secondary	Tmax	Up to ovulation or 18 months following injection, whichever comes first	up to 18 months
Secondary	Aggregate of individual Tmax measurements and parameters		Up to 18 months
Secondary	MPA concentration at Day 91 (C91)		91 days after injection
Secondary	Aggregate of individual C91 measurements and parameters		18 months after injection
Secondary	MPA concentration at Day 182 (C182)		182 days after injection
Secondary	Aggregate of individual C182 measurements and parameters		18 months after injection
Secondary	MPA concentration at Day 210 (C210)		210 days after injection
Secondary	Aggregate of individual C210 measurements and parameters		18 months after injection
Secondary	Area under the curve (AUC 0-182)		182 days after injection
Secondary	Terminal elimination half-life (t1/2)	Up to ovulation or 18 months following injection, whichever comes first	up to 18 months