Depo-SubQ Provera (medroxyprogesterone acetate) / Pfizer - LARVOL DELTA

Adolescent Subcutaneous (SQ) Injection Video Validation (clinicaltrials.gov) - P=N/A | N=30 | Active, not recruiting | Sponsor: Tufts Medical Center | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed

How do pro-social tendencies and provider biases affect service delivery? Evidence from the rollout of self-injection of DMPA-SC in Nigeria. (PubMed, BMC Womens Health) - "Provider biases may limit provision of DMPA-SC for SI, which could affect contraceptive equity and women's control over their own fertility, especially for younger, unmarried women. Targeted interventions that effectively address provider biases against young, unmarried women, potentially leveraging providers' underlying pro-social tendencies, may help ensure equity in client access to contraceptive self-care."

Journal

Examining the relationship between reproductive empowerment and contraceptive self-injection: Tackling the endogeneity problem. (PubMed, PLoS One) - "We did not find evidence of a significant relationship between reproductive empowerment and desire to continue self-injecting. Though there are limitations to this secondary data analysis, we recommend future research investigate this relationship using the methodology demonstrated to address endogeneity inherent in answering this critical question about self-care interventions."

Journal

Women's Perspectives on the Unique Benefits and Challenges of Self-Injectable Contraception: A Four-Country In-Depth Interview Study in Sub-Saharan Africa. (PubMed, Stud Fam Plann) - "Implementing self-injection (SI) of subcutaneous depot-medroxyprogesterone acetate (DMPA-SC) is a key self-care strategy for sexual and reproductive health, but SI uptake remains low, and assertions about the potential of SI to increase women's control over contraceptive use lack evidence...Interviews revealed SI's potential is, however, constrained by inherent limitations in the method; for example, it is often not private or accessible enough and many fear injecting themselves. SI has the most potential when implemented with programmatic solutions that mitigate challenges women experience or anticipate and allow more women to benefit from the privacy, easier access, and self-management that SI offers."

Interview • Journal • Long-acting Reversible Contraceptives

Novel dissolution methods for drug release testing of Long-Acting injectables. (PubMed, Int J Pharm) - "These adapters were validated and assessed using the long-acting injectable (LAI) suspension drug product Depo Provera 150® as well as its Q1/Q2 equivalents...A successful Level A IVIVC was developed for Depo SubQ Provera 104® and its Q1Q2 equivalents using USP apparatus type IV with a conical adapter design. The closed adapter design for apparatus type-II was also investigated for suitability with risperidone in situ forming implants. The adapter was able to securely retain and maintain the shape of the in situ forming implants and resulted in release profiles of up to one month with good discriminatory ability and low standard error (RSD≤5%). These novel adapters hold promise of wide use for in vitro release testing of different long-acting parenteral drug products."

Journal

Digital training for self-injectable contraceptives: a feasibility and acceptability pilot study. (PubMed, BMJ Sex Reprod Health) - "Training participants to administer self-injectable contraceptives via WhatsApp video call was feasible and acceptable. Training lessons learnt offer pragmatic adaptations for communicating about a practical skill via a digital channel. Further research is needed to ascertain the efficacy of digital training for self-injection and feasibility and acceptability for wider groups."

Journal • Long-acting Reversible Contraceptives

EPIC: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (clinicaltrials.gov) - P4 | N=108 | Completed | Sponsor: University of Alabama at Birmingham | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Feb 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone (clinicaltrials.gov) - P4 | N=40 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Jun 2024 ➔ Jun 2027 | Trial primary completion date: Dec 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date • CNS Disorders

Development of Mechanistic In Vitro-In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables. (PubMed, Pharmaceutics) - "The objectives of this study were as follows: (1) to use a mechanistic modeling approach to delineate the in vivo performance of DepoSubQ Provera® and formulation variants in preclinical species; (2) to predict human exposure based on the knowledge gained from the animal model. The PBPK model evaluated different elements involved in LAI administration and showed that (1) the effective in vivo particle size is potentially larger than the measured in vitro particle size, which could be due to particle aggregation at the injection site, and (2) local inflammation is a key process at the injection site that results in a transient increase in depot volume. This work highlights how a mechanistic modeling approach can identify critical physiological events and product attributes that may affect the in vivo performance of LAIs."

Journal • Preclinical • Inflammation

What is the impact of long-term usage of depot medroxyprogesterone acetate (DMPA) injectable contraceptives on the bone mineral density of patients with other associated risk factors for reduced bone mineral density? (ESCRH 2024) - "Background: Progestogen only injectable contraceptive methods, intra-muscular or sub-cutaneous depo medroxyprogesterone acetate (DMPA)are long-acting reversible methods of contraception, providing contraception through inhibition of ovulation. Initially, ten patients were reviewed. Two patients are still awaiting a DEXA scan request from their General Practitioner. One patient, aged 41, a smoker taking PPI with a 10-year un-interrupted history of DMPA usage had a normal DEXA scan."

Clinical • Epilepsy • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Long-acting Reversible Contraceptives • Osteoporosis • Rheumatology

Client Choices in DMPA-SC Injections: Understanding Factors Influencing Preferences from the Healthcare Provider's Perspective (ESCRH 2024) - "Background: The recent introduction of subcutaneous Depot medroxyprogesterone acetate (DMPA-SC) utilizing the Uniject™ injection system presents an opportunity to enhance the continuity of contraceptive use... These findings shed light on the factors perceived by providers in clients' decision-making processes regarding the mode of administration. Recognizing and addressing these factors are crucial steps toward advancing patient-centred healthcare practices and optimizing the acceptance and efficacy of DMPA-SC as a contraceptive method. Tailoring educational strategies and support services to align with clients' concerns is essential for promoting a more self-care approach within family planning programs."

Long-acting Reversible Contraceptives

Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients (clinicaltrials.gov) - P4 | N=653 | Recruiting | Sponsor: Northwestern University | Trial completion date: Oct 2023 ➔ Apr 2024 | Trial primary completion date: Oct 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date

Adolescent Subcutaneous (SQ) Injection Video Validation (clinicaltrials.gov) - P=N/A | N=30 | Enrolling by invitation | Sponsor: Tufts Medical Center | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Sep 2023 ➔ Dec 2026

Trial completion date • Trial primary completion date

EPIC: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (clinicaltrials.gov) - P4 | N=108 | Active, not recruiting | Sponsor: University of Washington | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Enrollment closed • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Service Delivery Considerations for Introducing New Injectable Contraceptives Lasting 4 and 6 Months in Nigeria and Uganda: A Qualitative Study. (PubMed, Glob Health Sci Pract) - "Family planning stakeholders in Nigeria and Uganda are supportive of expanding the method mix with new injectables, which they see as having the potential to meet the needs of more users. Concerted engagement of health providers, policymakers, and the community will be necessary for successful introduction once these new contraceptive products are available."

Journal • Long-acting Reversible Contraceptives

Health care provider and client experiences of counselling on depot medroxyprogesterone acetate subcutaneous (DMPA-SC) for self-injection in Malawi. (PubMed, PLOS Glob Public Health) - "Since the introduction of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in 2018, Malawi has achieved national coverage of trained providers in the public sector and steady increases in uptake of DMPA-SC...Provider-administered clients tended to credit their lack of uptake of self-injection to fear and lack of confidence, often blaming themselves instead of the quality of their counselling/training-even while many felt their counselling/training had been rushed or incomplete. Providers should be supported to overcome time- and resource-pressures to invest in counselling/training best practices, to ensure sufficient support is provided to clients interested in self-injection."

Journal

Evaluation of Subcutaneous Depot Medroxyprogesterone Acetate for Patient Self-Administration at North Florida/South Georgia Veterans Health System (ASHP 2023) - No abstract available

Clinical • Women's Health

A randomized crossover study to evaluate local tolerability following subcutaneous administration of a new depot medroxyprogesterone acetate contraceptive formulation. (PubMed, Contracept X) - P1 | "This study aimed to evaluate and compare local tolerability of investigational drug TV-46046 and reference drug Depo-subQ Provera 104, both containing medroxyprogesterone acetate (MPA) as an active ingredient. The previously underreported hypopigmentation associated with subcutaneous administration of MPA warrants further investigation and acceptability assessment among users of existing Depo-subQ 104 as well as careful monitoring of local tolerability of TV-46046 in future clinical trials. Registered at clinicaltrials.gov no: NCT02817464."

Journal • Pain

UMPALA: Impact of Contraceptives on Cervico-Vaginal Mucosa (clinicaltrials.gov) - P4 | N=112 | Completed | Sponsor: Eastern Virginia Medical School | Recruiting ➔ Completed | Trial primary completion date: Aug 2022 ➔ Dec 2022

Trial completion • Trial primary completion date • Inflammation • Mucositis

Implementation strategies to scale up self-administered depot medroxyprogesterone acetate subcutaneous injectable contraception: a scoping review. (PubMed, Syst Rev) - "This scoping review reported a wide range of interventions employed by countries and programs to scale up DMPA-SC self-administration but minimal evidence of the scale-up outcomes. Evidence from this review can help design better programs that improves access to quality family planning services to achieve the Sustainable Development Goals (SDG) targets 3.7. However, efforts should focus on rigorous implementation research that assess scaled up self-administered DMPA-SC interventions and report their outcomes."

Journal • Review • Long-acting Reversible Contraceptives

A Pilot Study of Adolescent and Young Adult Experience with Subcutaneous Depot Medroxyprogesterone Acetate. (PubMed, J Pediatr Adolesc Gynecol) - "In this small sample of patients within a children's hospital, overall experience with DMPA-SC was favorable. Clinicians caring for adolescents should consider including DMPA-SC in counseling when depot medroxyprogesterone acetate (DMPA) is indicated."

Journal • CNS Disorders

EPIC: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (clinicaltrials.gov) - P4 | N=105 | Recruiting | Sponsor: University of Washington | Phase classification: P1 ➔ P4

Phase classification • Human Immunodeficiency Virus • Infectious Disease

Patient's experience and satisfaction with self-administered subcutaneous depot medroxyprogesterone acetate use during the first year of COVID-19. (PubMed, Contraception) - "Self-administered DMPA-SC is an acceptable contraception option that provides an opportunity to maintain contraception access while eliminating need for an in-person visit. Thus, self-administered DMPA-SC should be included in clinicians' routine contraception counseling and provision, insurance companies need to cover this contraceptive without need for prior authorization, and pharmacies should consistently stock DMPA-SC."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

EPIC: Evaluation of Pharmacokinetic Drug-drug Interactions Between Hormonal Contraceptives and Doravirine-containing ART Among Women Living With HIV in South Africa (clinicaltrials.gov) - P1 | N=105 | Recruiting | Sponsor: University of Washington | Phase classification: P=N/A ➔ P1

Phase classification • Human Immunodeficiency Virus • Infectious Disease

Getting Up to Date with What Works: A Systematic Review on the Effectiveness and Safety of Task Sharing of Modern Methods in Family Planning Services. (PubMed, Biomed Res Int) - "Six studies met the inclusion criteria: five reported on self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) compared to administered by trained health providers; and one assessed tubal ligation performed by associate clinicians compared to advanced-level associate clinicians...These findings should be complemented with the evidence on the feasibility and acceptability of task sharing of these methods. The review protocol was registered with PROSPERO CRD42021283336."

Journal • Review