Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02732418
Other study ID # 834119
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2, 2016
Est. completion date May 15, 2018

Study information

Verified date June 2018
Source FHI 360
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle


Description:

This is a randomized, partially-blinded, multi-center, parallel-group study to evaluate and compare the PD and PK of MPA after a single SC injection of either 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL of Depo-Provera CI, and one cycle of Depo-subQ 104 use when injected in the abdomen, in women of reproductive age with confirmed ovulatory baseline cycle. Baseline ovulation will be confirmed in all women by measuring serum progesterone (P) approximately twice a week during the 2-3 weeks preceding expected menses. Between 48 and 60 participants (12-15 per group) with confirmed ovulation who meet other eligibility criteria will be enrolled and randomized to receive a single SC injection in the abdomen of 1 of 3 doses of Depo-Provera CI: 45 mg/0.3 mL, 75 mg/0.5 mL or 105 mg/0.7 mL or a single dose of Depo-subQ Provera (104 mg/0.65mL). Participants will be followed for 32 weeks (7.5 months) after the injection During the study participants will provide blood samples for MPA, P and estradiol (E2) prior to injection and then frequently at predefined time points through 7.5 months. In addition, for more accurate ascertainment of the PD response we will perform transvaginal ultrasound (TVS) and assess cervical mucus at predefined time points through 7.5 months. Information on adverse events and concomitant medications will be collected throughout the study. Information on acceptability will be collected at predefined time points through 7.5 months.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- has typical menstrual cycle of 24 to 35 days

- has confirmed ovulatory cycle during the pretreatment phase (serum progesterone = 4.7 ng/mL in 2 consecutive samples)

- is sterilized or using non hormonal intrauterine device (IUD)

- is in good general health as determined by a medical history and physical examination

- 18 to 40 years of age (inclusive)

- willing to provide informed consent and follow all study requirements

- has negative urine pregnancy test and has no desire to become pregnant in the subsequent 12 months

- has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive

- has hemoglobin =10.5 g/dL

Exclusion Criteria:

- has medical contraindications to depot medroxyprogesterone acetate (DMPA) [16]

- has undiagnosed mass in breast

- used DMPA in the past 12 months

- used a combined injectable contraceptive in the past 6 months

- used any of the following medications within 1 month prior to enrollment:

- any investigational drug

- prohibited drugs per protocol

- oral contraceptives

- Nuva-ring

- contraceptive patch

- levonorgestrel intrauterine system (LNG IUS) or contraceptive implant

- has been pregnant within last 3 months

- Is currently lactating

- in the opinion of the investigator, is potentially at elevated risk of HIV infection (HIV-positive partner, IV drug use by self or by partner)

- has more than one male sexual partner

- is using or plans to use prohibited drugs per protocol in the next 9 months

- has known sensitivity to MPA

- plans to move to another location in the next 9 months

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Depo-Provera CI
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
Depo-subQ 104
The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) 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
Primary Time to ovulation Time to ovulation indicated by time to reach rupture of the lead follicle based on transvaginal ultrasound (TVS) findings followed by serum progesterone level of >=4.7 ng/mL. The primary objective will be assessed by estimating the cumulative probability of return to ovulation through Month 7.5 from start of therapy in each test group based on the Kaplan-Meier product-limit method, with 95% confidence intervals derived using the complementary log-log transformation. 32 weeks after receiving drug
Secondary Measurement of serum MPA concentrations Measure of Peak Concentrations (Cmax) 32 weeks after receiving drug
Secondary Time to maximum serum concentration of MPA Time to reach peak concentration of MPA(Tmax) 32 weeks after receiving drug
Secondary Occurrence of adverse events 32 weeks after receiving drug
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 NCT02456584 - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods Phase 1
Completed NCT02718222 - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services N/A
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