Sayana® Press Self-injection Study in Malawi

Status Completed

Clinical Trial Summary

The feasibility of Sayana Press self-injection and the potential for this practice to increase contraceptive continuation has never been assessed in family planning programs in low-resource settings. The Malawi Ministry of Health (MOH) and the United States Agency for International Development (USAID) Malawi Mission requested the Advancing Partners and Communities (APC) project to assess self-injection of Sayana Press to inform their decision-making for procurement of Sayana Press and distribution through the health system in Malawi.

Clinical Trial Description

Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject (Pfizer, Inc., USA). Sayana Press was registered with the Medicines and Health Care Products Regulatory Agency (MHRA) and several other national regulatory agencies. The addition of this method is anticipated to aid in improving provision of family planning services in low-resource settings. As such, Sayana Press could be particularly useful in a country such as Malawi where injectable contraception is the most common method used. DMPA clients and providers are ready to explore the potential of self-injection of Sayana Press. A study conducted in a large family planning clinic in Edinburgh, Scotland found self-administration of DMPA-SC feasible and associated with similar continuation rates and satisfaction to clinician-administered DMPA-IM. A non-comparison study conducted in Planned Parenthood clinics in Florida found continuation of self-injected DMPA-SC high (74%) at the fourth injection. Participants in this study reported the injection to be easy and convenient and were likely to recommend self-administration to other women. Moreover, on September 29, 2014 Pfizer submitted a request to the MHRA to change the Sayana Press label to include self-injection.

If self-injection is found feasible, the results from this research will inform self-injection training materials, messages for providers and clients, and future scale-up efforts in Malawi and elsewhere in sub-Saharan Africa. ;

Study Design

Related Conditions & MeSH terms

Contraception

Clinical Trial Details

NCT number	NCT02293694
Study type	Interventional
Source	FHI 360
Contact
Status	Completed
Phase	N/A
Start date	September 17, 2015
Completion date	August 30, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02577601` - Impact of Combined Hormonal Contraceptives on UPA	Phase 4
Completed	`NCT03153644` - Improving Contraceptive Care for Women With Medical Conditions
Completed	`NCT04112095` - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Phase 3
Recruiting	`NCT05521646` - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative	N/A
Active, not recruiting	`NCT04291001` - Ovarian Function With ENG Implant and UPA Use	Early Phase 1
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed	`NCT03438682` - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting	`NCT01948882` - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women	N/A
Enrolling by invitation	`NCT04997499` - Adolescent Subcutaneous (SQ) Injection Video Validation	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03154125` - Sayana® Press Extension Study	Phase 3
Withdrawn	`NCT03725358` - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.	N/A
Completed	`NCT02957630` - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"	Phase 1/Phase 2
Completed	`NCT02718222` - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services	N/A
Completed	`NCT02456584` - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods	Phase 1
Recruiting	`NCT02121067` - LNG-IUS at 2 Weeks Postpartum	Phase 4
Terminated	`NCT02169869` - Immediate Postplacental IUD Insertion	N/A
Recruiting	`NCT02292056` - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions	N/A
Withdrawn	`NCT01930994` - Kenya Sino-implant (II) PK Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.