Sayana® Press Extension Study

Contraception Clinical Trial

Official title:

A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154125
• Other study ID #: 926400
• Status: Completed
• Phase: Phase 3
• Start date: September 22, 2017
• Est. completion date: May 30, 2020

Study information

• Verified date: August 2020
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized clinical trial designed to evaluate the effectiveness, safety and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) for 3 treatment cycles (12 months) of use.

Description:

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate the effectiveness, PK, safety, and acceptability of Sayana® Press when injected every 4 months (17-18 weeks) rather than the currently prescribed 3-month (12-14 weeks) regimen. A total of 750 healthy, sexually active women aged 18 to 35 years with regular menstrual cycles and no DMPA use in the previous 12 months will be enrolled and followed for pregnancy. Among all enrolled, 710 will be randomized to receive injections in the abdomen or upper thigh in accordance with the PATH Sayana® injection instructions, which are consistent with prescribing information, for the primary effectiveness analysis. An additional 40 women will be randomized to receive injections subcutaneously in the back of the upper arm to assess whether differences in PK may exist which could impact the grace period for reinjections for that injection site. A single MPA serum sample will be collected from all participants at baseline. All participants will receive re-injections at month 4 and month 8, and complete their scheduled follow-up at month 12. There will be a plus 7-day grace period for re-injections, but women who are up to 28 days late may continue treatment if they have a negative urine pregnancy test. Urine pregnancy testing will be performed at month 4, at study exit and at any other time during the study if clinically indicated. Participants will be evaluated for injection site reactions and asked to provide information on adverse events, prohibited concomitant medication and other contraceptive use, vaginal bleeding, and method acceptability at all regular follow-up visits (i.e., not including the PK visits at Months 2 and 3). Serious adverse events and adverse events leading to product withdrawal, will be recorded throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• not pregnant and no desire to become pregnant in the next 18 months
• regular menstrual cycles (25 to 35 days in length when not using hormonal contraception, pregnant, or lactating)
• at risk of pregnancy (no diagnosis of infertility, no history of tubal ligation or hysterectomy, and an average of 1 or more unprotected acts of vaginal intercourse per month)
• in good general health as determined by a medical history
• 18 to 35 years of age, inclusive
• willing to provide informed consent, follow all study requirements, and rely on Sayana® Press injected every 4 months as the only means of contraception for 12 months
• has only one sexual partner and expects to have that same sexual partner for the next 12 months

Exclusion Criteria:

• has a primary partner who has received a vasectomy or is otherwise sterile
• medical contraindications to depot medroxyprogesterone acetate (DMPA) per World Health Organization medical eligibility criteria for contraceptive use
• known HIV-infection (for her or her partner)
• diagnosis or treatment for a sexually transmitted infection in the past month (for her or a partner), excluding recurrent herpes or condyloma
• received an injection of a progestin-only containing contraceptive (DMPA or norethisterone enanthate) in the past 12 months
• received an injection of a combined injectable contraceptive in the past 6 months
• known or suspected allergic reaction to DMPA
• used a levonorgestrel-releasing intrauterine system, NuvaRing, contraceptive patch, oral contraceptives or a contraceptive implant in the 7 days prior to enrollment (PK cohort only)
• previous (within 1 month prior to enrollment), current or planned (in the next 12 months) use of an investigational drug, prohibited drug per protocol or other drug which in the opinion of the site investigator could complicate study findings
• has been pregnant in the past month
• is lactating
• plans to move to another location in the next 12 months
• has a social or medical condition which in the opinion of the site investigator would make study participation unsafe, or interfere with adherence to protocol requirements.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Sayana® Press
The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection.

Locations

Country	Name	City	State
Brazil	Universidade Estadual de Campinas (UNICAMP)	Campinas
Chile	Instituto Chileno De Medicina Reproductiva (ICMER)	Santiago
Dominican Republic	Asociación Dominicana Pro Bienestar de la Familia, Inc. (PROFAMILIA)	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Countries where clinical trial is conducted

Brazil,  Chile,  Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Return to ovulation among a subset of study participants who received month 4 and month 8 injections and plan to use non-hormonal methods of contraception, or no contraception for up to a maximum of 12 months from the last study injection.	Ovulation is defined as a single elevated serum progesterone (P =4.7 ng/mL) or a confirmed pregnancy test.	A maximum of 12 months from the last study injection.
Primary	Occurrence of pregnancy	Pregnancy is defined as having a positive urine pregnancy test. Positive urine tests will be confirmed by ultrasound and/or serum hCG testing whenever possible. The primary efficacy analysis will be based on the pregnancy Pearl Index, computed as the number of pregnancies that occur during the treatment period multiplied by 100 and divided by the number of WY of treatment contributed to the Treated Analysis Set among women receiving injections in the abdomen or thigh.	12 months after treatment initiation
Secondary	Serum MPA concentrations (trough concentrations, accumulation and apparent terminal half-life of MPA) in a subset of 120 participants	Pharmacokinetic endpoints include serum MPA concentrations at month 2, 3, 4, 8, and 12.	12 months after treatment initiation
Secondary	Occurrence of serious adverse events (SAEs) and adverse events (AEs) leading to product withdrawal	The overall safety of study drug will be assessed throughout the study by evaluating the occurrence of SAEs and AEs leading to product discontinuation, blood pressure and weight at regularly scheduled visits, and changes in bleeding pattern.	12 months after treatment initiation
Secondary	Acceptability of Sayana® Press	Perception of bleeding patterns and other responses to acceptability questions will be summarized using descriptive statistics based on routine questions asked at regularly scheduled visits (enrollment, months 4 and 8, and final).	12 months after treatment initiation