Emergency ContraceptionEarly Phase 1NCT03395756
Depot Medroxyprogesterone Acetate as Emergency Contraception
A Early Phase 1 study testing Depot-Medroxyprogestereone Acetate in people with Emergency Contraception and Contraception, run by University of Southern California at 1 site in United States.
Trial summary
Background: The prevalence of repeat unprotected intercourse after EC use in the same cycle demonstrate the need for more self-bridging emergency contraceptive options. We propose the use of intramuscular Depot Medroxyprogesterone acetate (DMPA) as EC, which has been shown to inhibit follicular activity within 24… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Contraception, Contraception
- What is being tested?
- Depot-Medroxyprogestereone Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 30 Oct 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women of reproductive age (18-39 years old) with BMI 18-30 kg/m2
- Regular menses for the last 3 months
- Cycle duration 24 to 35 days
- Women using copper IUD, sterilization, or barrier methods as current or preferred birth control method, and women reporting exclusive sex with women
- English- or Spanish-speaking
Who cannot join
- Any contraindications to progesterone contraception per teh CDC Medical Eligibility Criteria (Category 3 or 4)
- On medications that can alter, or be altered by, progesterone contraceptive steroid hormone (e.g., aminoglutethimide or other anti-steroid medication)
- Use of any hormonal contraceptive pill, patch, or vaginal ring in the month prior to recruitment
- Use of depot-medroxyprogesterone acetate in teh 10 months prior to recruitment
- Currently pregnant and/or breastfeeding
- History of allergic reaction to depot medroxyprogesterone acetate (rash, urticaria, anaphylaxis)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California Keck Medical Center
Los Angeles, California, 90033
About this study
Official title: Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception
Background:
The prevalence of repeat unprotected intercourse after EC use in the same cycle demonstrate the need for more self-bridging emergency contraceptive options. We propose the use of intramuscular Depot Medroxyprogesterone acetate (DMPA) as EC, which has been shown to inhibit follicular activity within 24 hours, and provide on-going contraception via suppression or disruption of ovulation.
Read more
Objective:
The objective of this study is to explore the potential of depot medroxyprogesterone acetate (DMPA) given as a 150-mg intramuscular injection for use as an emergency contraceptive.
Study population:
Healthy regularly menstruating women aged 18-39 years old will be invited to participate if they fulfill inclusion criteria. The participants will undergo a screening visit during the midluteal phase of their cycle, and will be enrolled if a serum progesterone level is >3ng/ml.
Methodology:
Participants will be assigned to one of three groups based on leading follicle size. Starting cycle Day 8, transvaginal ultrasounds will be performed to assess the size of the leading follicle. Once the follicle has reached the pre-assigned size, 150 mg IM DMPA will be administered. Blood will be collected for baseline hormonal assays. For 5 consecutive days, daily blood will be drawn for hormonal assays and daily transvaginal ultrasound will be performed to assess for signs of ovulation. The participant will then return for twice weekly progesterone levels for 2 weeks for study completion.
Read the detailed description
The proposed study will enroll 36 healthy, non-pregnant, non-breastfeeding, reproductive age women with regular ovulatory cycles. Potential participants will undergo screening, which will include a history, physical exam, assessment of vital signs, and blood draw for assessment of ovulation via mid-luteal progesterone levels. If her progesterone level confirms ovulatory status (> 3 ng/ml), she will be offered enrollment and assigned to one of three follicular phase groups based on her leading follicle size in the next cycle: 12-14 mm, 15-17 mm, and ≥18 mm. To determine follicle size, participants will receive serial transvaginal ultrasound (TVUS) scans of their ovarian follicles starting on cycle day 8 of the next menstrual cycle. The scans will be performed three times weekly to identify her leading follicle. Once the leading follicle has reached its assigned size, DMPA will be administered. Blood samples will be obtained prior to administration for baseline hormonal assays. One hour after administration, blood will be drawn for MPA levels. For the following five consecutive days, the participant will undergo daily TVUS to detect signs of follicular rupture and blood draws to assess serum markers of ovulation (estradiol, progesterone, and luteinizing hormone). On the first day, 24 hours after DMPA administration, blood will be drawn for MPA levels as well. After five days, the participant will return twice weekly for two weeks to provide serum progesterone levels to detect any delayed ovulation or ovulatory dysfunction. At the final visit, she will fill out a simple survey to assess her satisfaction with DMPA as an EC method, and whether she would recommend this method to others.
- Conditions
- Emergency Contraception, Contraception
- Being tested
- Depot-Medroxyprogestereone Acetate
- Keywords
- Depot Medroxyprogesterone acetate, Injectable birth control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depot-Medroxyprogestereone AcetateDrug
Administration of 150 mg intramuscular depot medroxyprogesterone acetate
| Study group | Role | What they receive |
|---|---|---|
| 12-14 mm follicle size group | Active comparator | Once the participant's leading follicle reaches 12-14mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. Receives: Drug: Depot-Medroxyprogestereone Acetate |
| 15-17 mm follicle size group | Active comparator | Once the participant's leading follicle reaches 15-17mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. Receives: Drug: Depot-Medroxyprogestereone Acetate |
| 18 mm or greater follicle size group | Active comparator | Once the participant's leading follicle reaches 18mm or greater, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. Receives: Drug: Depot-Medroxyprogestereone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation
Follicle rupture on ultrasound preceded by LH surge 21 IU/L or greater, followed by progesterone level 3 ng/ml or greater.
Measured: 5 days to 3 weeks
Ovulation Suppression
Lack of follicular rupture on ultrasound with or without appropriate LH surge of 21 IU/L or greater and without elevation in progesterone levels to 3 ng/ml or greater
Measured: 5 days to 3 weeks
Ovulatory dysfunction
Rupture of leading follicle without appropriate LH surge (less than 21 IU/L) and without appropriate progesterone elevation after rupture (less then 3 ng/ml)
Measured: 5 days to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start31 Aug 2018
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants in this study will be assigned to one of three groups based on leading follicle size: 12-14 mm, 15-17mm, and 18 mm or greater. Each group will receive the same medication (intramuscular depot medroxyprogesterone acetate), and be followed in the same manner for five consecutive days after administration with transvaginal ultrasound and blood draws for hormonal assays (progesterone, estradiol, and luteinizing hormone levels)
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Brian T. Nguyen, MD MSc, University of Southern California
- Investigators
- Robyn L Schickler, MD, Principal investigator, University of Southern CaliforniaBrian Nguyen, MD, MSCP, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395756
- Sponsor's protocol ID
- HS-17-01006
- Status last verified
- Nov 2020
- First submitted
- 4 Jan 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniels K, Jones J, Abma J. Use of emergency contraception among women aged 15-44: United States, 2006-2010. NCHS Data Brief. 2013 Feb;(112):1-8.
PubMed 23742711ESHRE CapriWorkshop Group. Emergency contraception. Widely available and effective but disappointing as a public health intervention: a review. Hum Reprod. 2015 Apr;30(4):751-60. doi: 10.1093/humrep/dev019. Epub 2015 Feb 11.
PubMed 25678571Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.
PubMed 21920190Turok DK, Gurtcheff SE, Handley E, Simonsen SE, Sok C, North R, Frost C, Murphy PA. A survey of women obtaining emergency contraception: are they interested in using the copper IUD? Contraception. 2011 May;83(5):441-6. doi: 10.1016/j.contraception.2010.08.011. Epub 2010 Sep 29.
PubMed 21477687Mishell DR Jr. Pharmacokinetics of depot medroxyprogesterone acetate contraception. J Reprod Med. 1996 May;41(5 Suppl):381-90.
PubMed 8725700Ortiz A, Hirol M, Stanczyk FZ, Goebelsmann U, Mishell DR. Serum medroxyprogesterone acetate (MPA) concentrations and ovarian function following intramuscular injection of depo-MPA. J Clin Endocrinol Metab. 1977 Jan;44(1):32-8. doi: 10.1210/jcem-44-1-32.
PubMed 833262Fotherby K, Koetsawang S, Mathrubutham M. Pharmacokinetic study of different doses of Depo Provera. Contraception. 1980 Nov;22(5):527-36. doi: 10.1016/0010-7824(80)90105-5.
PubMed 6451351Petta CA, Faundes A, Dunson TR, Ramos M, DeLucio M, Faundes D, Bahamondes L. Timing of onset of contraceptive effectiveness in Depo-Provera users. II. Effects on ovarian function. Fertil Steril. 1998 Nov;70(5):817-20. doi: 10.1016/s0015-0282(98)00309-4.
PubMed 9806559Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004 Dec;70(6):442-50. doi: 10.1016/j.contraception.2004.05.007.
PubMed 15541405Shen J, Che Y, Showell E, Chen K, Cheng L. Interventions for emergency contraception. Cochrane Database Syst Rev. 2017 Aug 2;8(8):CD001324. doi: 10.1002/14651858.CD001324.pub5.
PubMed 28766313Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med. 1995 Dec 7;333(23):1517-21. doi: 10.1056/NEJM199512073332301.
PubMed 7477165Long-term reversible contraception. Twelve years of experience with the TCu380A and TCu220C. Contraception. 1997 Dec;56(6):341-52.
PubMed 9494767Harper CC, Speidel JJ, Drey EA, Trussell J, Blum M, Darney PD. Copper intrauterine device for emergency contraception: clinical practice among contraceptive providers. Obstet Gynecol. 2012 Feb;119(2 Pt 1):220-6. doi: 10.1097/AOG.0b013e3182429e0d.
PubMed 22270272Wu S, Godfrey EM, Wojdyla D, Dong J, Cong J, Wang C, von Hertzen H. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. BJOG. 2010 Sep;117(10):1205-10. doi: 10.1111/j.1471-0528.2010.02652.x. Epub 2010 Jul 7.
PubMed 20618314Rowe P, Farley T, Peregoudov A, Piaggio G, Boccard S, Landoulsi S, Meirik O; IUD Research Group of the UNDP/UNFPA/WHO/World Bank Special Programme of Research; Development and Research Training in Human Reproduction. Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A. Contraception. 2016 Jun;93(6):498-506. doi: 10.1016/j.contraception.2016.02.024. Epub 2016 Feb 23.
PubMed 26916172
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception
- ClinicalTrials.gov ID
- NCT03395756
- Acronym / sponsor ID
- HS-17-01006
- Conditions
- Emergency Contraception, Contraception
- Keywords
- Depot Medroxyprogesterone acetate, Injectable birth control
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The prevalence of repeat unprotected intercourse after EC use in the same cycle demonstrate the need for more self-bridging emergency contraceptive options. We propose the use of intramuscular Depot Medroxyprogesterone acetate (DMPA) as EC, which has been shown to inhibit follicular activity within 24 hours, and provide on-going contraception via suppression or disruption of ovulation.
Objective:
The objective of this study is to explore the potential of depot medroxyprogesterone acetate (DMPA) given as a 150-mg intramuscular injection for use as an emergency contraceptive.
Study population:
Healthy regularly menstruating women aged 18-39 years old will be invited to participate if they fulfill inclusion criteria. The participants will undergo a screening visit during the midluteal phase of their cycle, and will be enrolled if a serum progesterone level is >3ng/ml.
Methodology:
Participants will be assigned to one of three groups based on leading follicle size. Starting cycle Day 8, transvaginal ultrasounds will be performed to assess the size of the leading follicle. Once the follicle has reached the pre-assigned size, 150 mg IM DMPA will be administered. Blood will be collected for baseline hormonal assays. For 5 consecutive days, daily blood will be drawn for hormonal assays and daily transvaginal ultrasound will be performed to assess for signs of ovulation. The participant will then return for twice weekly progesterone levels for 2 weeks for study completion.
Detailed description
The proposed study will enroll 36 healthy, non-pregnant, non-breastfeeding, reproductive age women with regular ovulatory cycles. Potential participants will undergo screening, which will include a history, physical exam, assessment of vital signs, and blood draw for assessment of ovulation via mid-luteal progesterone levels. If her progesterone level confirms ovulatory status (> 3 ng/ml), she will be offered enrollment and assigned to one of three follicular phase groups based on her leading follicle size in the next cycle: 12-14 mm, 15-17 mm, and ≥18 mm. To determine follicle size, participants will receive serial transvaginal ultrasound (TVUS) scans of their ovarian follicles starting on cycle day 8 of the next menstrual cycle. The scans will be performed three times weekly to identify her leading follicle. Once the leading follicle has reached its assigned size, DMPA will be administered. Blood samples will be obtained prior to administration for baseline hormonal assays. One hour after administration, blood will be drawn for MPA levels. For the following five consecutive days, the participant will undergo daily TVUS to detect signs of follicular rupture and blood draws to assess serum markers of ovulation (estradiol, progesterone, and luteinizing hormone). On the first day, 24 hours after DMPA administration, blood will be drawn for MPA levels as well. After five days, the participant will return twice weekly for two weeks to provide serum progesterone levels to detect any delayed ovulation or ovulatory dysfunction. At the final visit, she will fill out a simple survey to assess her satisfaction with DMPA as an EC method, and whether she would recommend this method to others.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants in this study will be assigned to one of three groups based on leading follicle size: 12-14 mm, 15-17mm, and 18 mm or greater. Each group will receive the same medication (intramuscular depot medroxyprogesterone acetate), and be followed in the same manner for five consecutive days after administration with transvaginal ultrasound and blood draws for hormonal assays (progesterone, estradiol, and luteinizing hormone levels)
| Arm | Type | Receives |
|---|---|---|
| 12-14 mm follicle size group | Active comparator | Drug: Depot-Medroxyprogestereone AcetateOnce the participant's leading follicle reaches 12-14mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. |
| 15-17 mm follicle size group | Active comparator | Drug: Depot-Medroxyprogestereone AcetateOnce the participant's leading follicle reaches 15-17mm, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. |
| 18 mm or greater follicle size group | Active comparator | Drug: Depot-Medroxyprogestereone AcetateOnce the participant's leading follicle reaches 18mm or greater, she will receive an IM administration of 150 mg Depot-Medroxyprogesterone Acetate. Prior to administration, she will have blood drawn for baseline progesterone, estradiol, and LH levels. One hour after receiving the injection, she will have blood drawn for medroxyprogesterone acetate levels. The next day, she will undergo a transvaginal ultrasound to assess the leading follicle and will have blood drawn for progesterone, estradiol, LH, and medroxyprogesterone acetate levels. For the next 4 consecutive days, she will have daily transvaginal ultrasounds to assess for signs of follicular rupture, and blood draws for hormonal assays. After, she will return twice weekly for two weeks for blood draw for progesterone levels. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women of reproductive age (18-39 years old) with BMI 18-30 kg/m2
- Regular menses for the last 3 months
- Cycle duration 24 to 35 days
- Women using copper IUD, sterilization, or barrier methods as current or preferred birth control method, and women reporting exclusive sex with women
- English- or Spanish-speaking
Key exclusion criteria (6 listed)
- Any contraindications to progesterone contraception per teh CDC Medical Eligibility Criteria (Category 3 or 4)
- On medications that can alter, or be altered by, progesterone contraceptive steroid hormone (e.g., aminoglutethimide or other anti-steroid medication)
- Use of any hormonal contraceptive pill, patch, or vaginal ring in the month prior to recruitment
- Use of depot-medroxyprogesterone acetate in teh 10 months prior to recruitment
- Currently pregnant and/or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depot-Medroxyprogestereone AcetateAdministration of 150 mg intramuscular depot medroxyprogesterone acetate | Drug | 12-14 mm follicle size group, 15-17 mm follicle size group, 18 mm or greater follicle size group |
Primary outcome
Ovulation
Time frame: 5 days to 3 weeks
Follicle rupture on ultrasound preceded by LH surge 21 IU/L or greater, followed by progesterone level 3 ng/ml or greater.
Ovulation Suppression
Time frame: 5 days to 3 weeks
Lack of follicular rupture on ultrasound with or without appropriate LH surge of 21 IU/L or greater and without elevation in progesterone levels to 3 ng/ml or greater
Ovulatory dysfunction
Time frame: 5 days to 3 weeks
Rupture of leading follicle without appropriate LH surge (less than 21 IU/L) and without appropriate progesterone elevation after rupture (less then 3 ng/ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 23742711Daniels K, Jones J, Abma J. Use of emergency contraception among women aged 15-44: United States, 2006-2010. NCHS Data Brief. 2013 Feb;(112):1-8.
- Background: PubMed 25678571ESHRE CapriWorkshop Group. Emergency contraception. Widely available and effective but disappointing as a public health intervention: a review. Hum Reprod. 2015 Apr;30(4):751-60. doi: 10.1093/humrep/dev019. Epub 2015 Feb 11.
- Background: PubMed 21920190Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011 Oct;84(4):363-7. doi: 10.1016/j.contraception.2011.02.009. Epub 2011 Apr 2.
- Background: PubMed 21477687Turok DK, Gurtcheff SE, Handley E, Simonsen SE, Sok C, North R, Frost C, Murphy PA. A survey of women obtaining emergency contraception: are they interested in using the copper IUD? Contraception. 2011 May;83(5):441-6. doi: 10.1016/j.contraception.2010.08.011. Epub 2010 Sep 29.
- Background: PubMed 8725700Mishell DR Jr. Pharmacokinetics of depot medroxyprogesterone acetate contraception. J Reprod Med. 1996 May;41(5 Suppl):381-90.
- Background: PubMed 833262Ortiz A, Hirol M, Stanczyk FZ, Goebelsmann U, Mishell DR. Serum medroxyprogesterone acetate (MPA) concentrations and ovarian function following intramuscular injection of depo-MPA. J Clin Endocrinol Metab. 1977 Jan;44(1):32-8. doi: 10.1210/jcem-44-1-32.
- Background: PubMed 6451351Fotherby K, Koetsawang S, Mathrubutham M. Pharmacokinetic study of different doses of Depo Provera. Contraception. 1980 Nov;22(5):527-36. doi: 10.1016/0010-7824(80)90105-5.
- Background: PubMed 9806559Petta CA, Faundes A, Dunson TR, Ramos M, DeLucio M, Faundes D, Bahamondes L. Timing of onset of contraceptive effectiveness in Depo-Provera users. II. Effects on ovarian function. Fertil Steril. 1998 Nov;70(5):817-20. doi: 10.1016/s0015-0282(98)00309-4.
- Background: PubMed 15541405Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75-mg dose given on the days preceding ovulation. Contraception. 2004 Dec;70(6):442-50. doi: 10.1016/j.contraception.2004.05.007.
- Background: PubMed 28766313Shen J, Che Y, Showell E, Chen K, Cheng L. Interventions for emergency contraception. Cochrane Database Syst Rev. 2017 Aug 2;8(8):CD001324. doi: 10.1002/14651858.CD001324.pub5.
- Background: PubMed 7477165Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med. 1995 Dec 7;333(23):1517-21. doi: 10.1056/NEJM199512073332301.
- Background: PubMed 9494767Long-term reversible contraception. Twelve years of experience with the TCu380A and TCu220C. Contraception. 1997 Dec;56(6):341-52.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robyn L Schickler, MD principal investigator
University of Southern California
Brian Nguyen, MD, MSCP principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Depot-Medroxyprogestereone Acetate in people with Emergency Contraception and Contraception, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovulation (time frame: 5 days to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395756, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.