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Depo Provera

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241. Exploratory Pharmacodynamic Study of Tenofovir-Based Products

had at least two spontaneous menses since pregnancy outcome Injection of Depo-Provera in the last 10 months or use of other progestin-only based contraceptive (including hormonal IUD) Currently breastfeeding or planning to breastfeed during the course of the study History of sensitivity/allergy to any component of the study products, topical anesthetic, or to both silver nitrate and Monsel's solution In the last three months, diagnosed with or treated for any STI, by self report Positive test

2016 Clinical Trials

242. Exploratory Study for Allergy Relief Onset

during ragweed challenge Symptom Induction Phase of each Treatment Visit; Body Mass Index (BMI) in the range of 18 to 30 kg/m2 Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP

2016 Clinical Trials

243. Substrate Utilization, Exercise Performance, and Skeletal Muscle Response to Energy Deficit and Altitude Acclimatization

birth control, NuvaRing®, Depo Provera®, etc.) Have supervisor approval (permanent party military) Not taking any medications and/or willing to refrain from all medication use 4 wk prior to and throughout the entire study period, unless provided/approved by the US Army Research Institute of Environmental Medicine (USARIEM) Office of Medical Support and Oversight (OMSO) or medical oversight at Pikes Peak, Colorado organized through OMSO. Willing to refrain from alcohol, smoking any nicotine product

2016 Clinical Trials

244. Open Label Efficacy and Safety of Anti-MAP (Mycobacterium Avium Ssp. Paratuberculosis) Therapy in Adult Crohn's Disease

of treatment with open label RHB-104 (Refer to Appendix 13) White blood cell count ≥ 3.5x109 at screening (RHB-104-01 Visit Week 26 visit or Optional Screening visit) Subject agrees to use the following effective contraceptive methods diaphragm, cervical cap, contraceptive sponge or condom) with spermicidal foam/gel/cream/suppository IUD (intrauterine device) /IUS (intrauterine system) progestogen injection (Depo-Provera®) throughout the study and for at least 6 weeks after last study drug administration

2016 Clinical Trials

245. Benralizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

an effective form of birth control (confirmed by the Investigator). Effective forms of birth control include: true sexual abstinence, a vasectomized sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD intrauterine device/IUS levonogestrel Intrauterine system, Depo-Provera(tm) injections, oral contraceptive, and Evra Patch(tm) or Nuvaring(tm). WOCBP must agree to use effective method of birth control, as defined above, from enrolment, throughout the study duration and within

2016 Clinical Trials

246. Multicenter Double-Blind Randomized Split-Face Study to Evaluate Revanesse® Ultra vs Restylane® for Correction of NLF

implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used

2016 Clinical Trials

247. Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF

. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives

2016 Clinical Trials

248. Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area

contraceptives, contraceptive injections, combined pill, progestin-only pill, hormone-releasing transdermal patch or vaginal ring, and depot medroxyprogesterone acetate injection (Depo-Provera), OR Male sex partners must have had a vasectomy > /= 3 months prior to first vaccination, OR Practice abstinence defined as refraining from heterosexual intercourse from 30 days before first vaccination until the end of the study. Female subjects must agree to not donate eggs (ova, oocytes) from the start of screening

2016 Clinical Trials

249. Evaluation of the Efficacy and Safety of LevoCept

intercourse earlier in current cycle Subject who anticipates separation from her partner for more than 1 cycle within the next 12 months; A previously inserted IUD that has not been removed by the time LevoCept is placed; History of previous IUD complications, such as perforation, expulsion, infection (pelvic inflammatory disease) or pregnancy with IUD in place.; Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months; 5.1 Must have had 2 normal menstrual cycles since the last

2016 Clinical Trials

250. Four Way Crossover Closed Loop With Exercise Detection

all clinic visits. Willingness to sign informed consent and HIPAA documents. Exclusion Criteria: Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence. Any cardiovascular disease, defined

2016 Clinical Trials

251. A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression

) Participants will remain on baseline mood stabilizer pharmacotherapy with lithium during the study. They will need to have been on lithium with stable therapeutic blood levels for at least two weeks prior to randomization and agree not to change medications during the study. Women of child bearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, double barrier methods), if sexually active. Depo Provera is acceptable if it is started 3 months prior

2016 Clinical Trials

252. Intranasal Oxytocin in Hypothalamic Obesity

, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study. Hypothalamic obesity, defined for the purposes of this protocol as: previously diagnosed with a brain tumor* currently overweight or obese (BMI > 85%ile for age/sex for < 18 years, BMI > 25 kg/m2 for 18 - 21 years) has at least one other endocrinopathy, indicating hypothalamic damage rate of annualized weight gain during any 6 month period (given variability in clinical course) preceding

2016 Clinical Trials

253. Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers

hormonal method of contraception (e.g., Depo-Provera) during the last 6 months prior to the first dose. Use (within 28 days prior to first dose) of other hormonal contraceptive method. Use of any prescription drugs (except thyroid hormone supplements) or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort), within 28 days prior to the first dose until study completion, any over-the-counter (OTC) medication (including paracetamol) or dietary supplements (vitamins included) within 14

2016 Clinical Trials

254. An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

Use of oral contraceptives in the 30 days preceding screening. Use of Depo-Provera® in the preceding 10 months. Use of GnRHas (e.g. Lupron Depot) within 3 months prior to screening (Lupron Depot must have a wash-out period of 3 months prior to screening) Has an IUD in place Current cervical dysplasia classified as Atypical Squamous Cells of Undetermined Significance (ASCUS) associated with high-risk human papilloma virus (HPV) Current diagnosis of Low/High Grade Squamous Intraepithelial Lesion

2016 Clinical Trials

255. Compare Daily Ulipristal Acetate and Combined Oral Contraceptive Effects on Breast Epithelial Cell Proliferation

menstrual cycles (3 bleeding episodes) prior to screening. If previous use of injectable Depo Provera, subject must have had two normal menstrual cycles (3 bleeding episodes) prior to screening. Not at risk for pregnancy: Using a copper intra uterine device (IUD), or Willing to protect all further acts of intercourse with condoms, or Not hetero-sexually active, or Having undergone previous tubal ligation, or Partner sterilized or vasectomized. Body Mass Index (BMI) < 30 kg/m2 and not having previously

2016 Clinical Trials

256. Dolutegravir in Reservoirs

potential (FCB) must agree to either commit to continued abstinence from heterosexual intercourse or to use a reliable form of birth control such as oral contraceptive pills, intrauterine device, Nexplanon, Depo Provera, permanent sterilization, or another acceptable method, as determined by the investigator for the duration of the study. FCB are defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy or have not been naturally postmenopausal for at least 24

2016 Clinical Trials

257. Dose-Escalation Study of Ponatinib, a FLT3 Inhibitor, With and Without Combination of 5-Azacytidine, in Patients With FLT3-Mutated Acute Myeloid Leukemia (AML)

effective contraceptive methods during the study. Adequate forms of contraception are double barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptives, intrauterine devices, and tubal ligation. Male patients with female partners who are of childbearing potential: Recommendation is for male and partner to use at least 2 effective contraceptive methods, as described above, during the study. Females must

2016 Clinical Trials

258. Omental Islet Transplant

discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control from the following list: oral contraceptives, Norplant®, Depo-Provera®, intrauterine device (IUD), barrier devices with spermicide. Condoms used alone are not acceptable. Instead of the male condom, it is acceptable to use

2016 Clinical Trials

259. Fertility in Healthy Premenopausal Women

-only) within five days enrollment. Contraceptive patch (such as Ortho Evra®) within seven days of enrollment. Vaginal contraceptive ring (such as NuvaRing™) within 21 days of enrollment. Contraceptive injection (such as Depo-Provera®) within 90 days of enrollment. Intra-uterine system (IUS) within 90 days of enrollment. An intra-uterine device (IUD) made of copper does not exclude the patient from participating in this study. Subdermal contraceptive implants (such as Nexplanon®) within 90 days

2016 Clinical Trials

260. Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis

a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), Essure® permanent birth control, and abstinence with a documented second acceptable method of birth control

2016 Clinical Trials

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